Worldwide Distribution - US (nationwide) and Internationally to:  CZECH REPUBLIC  ALBANIA  ALGERIA  ARGENTINA  AUSTRALIA  AUSTRIA  AZARBAIJAN  BAHAMAS  BANGLADESH  BELGIUM  BRAZIL  BULGARIA  CAYMAN ISLANDS  CHILE  CHINA  COLUMBIA  COSTA RICA  CROATIA  CUBA  CZECHOSLOVAKIA  DENMARK  DOMINICAN REPUB  ECUADOR  EGYPT  ESTONIA  FINLAND  FRANCE  GABON  GERMANY  GREECE  HONG KONG  HUNGARY  ICELAND  INDIA  INDONESIA  IRAN  IRAQ  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KENYA  KOREA SOUTH  KUWAIT  LATVIA  LEBANON  LIBYA  LITHUANIA  MACEDONIA  MALAYSIA  MAURITIUS  MEXICO  MOLDAVIA  MONGOLIA  MOROCCO  NEPAL  NETHERLANDS  NETHERLANDS ANT  NEW ZEALAND  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  Papua New Guinea  PARAGUAY  PERU  PHILIPPINES  POLAND  PORTUGAL  PUORTO RICO  QATAR  REUNION  ROMANIA  RUSSIAN FEDERAT  SAUDI ARABIA  SERBIA  SINGAPORE  SLOVENIA  SOUTH AFRICA  SPAIN  SUDAN  SWEDEN  SWITZERLAND  SYRIA  TAIWAN  TANZANIA  THAILAND  TUNISIA  TURKEY  UKRAINE  UNITED ARAB EMI  United Arab Emirates  UNITED KINGDOM  URUGUAY  USA  UZBEKISTAN  VENEZUELA  VIETNAM  YEMEN  GUADELOUPE  SYRIAN ARAB REPUBLIC
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038  This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography
Loss of key image functionality due to a bent pedal of the Footswitch.
Foot Switches:  452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m;  452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2;  459800415531 Wireless Footswitch 3P;  459800415561 Wireless footswitch set 3P.
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0  The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Addition
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
Product was distributed to distribution centers in AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, and WI. Further distribution to retail stores was likely to more states.
Some bags of product showed evidence of mold.
US: CO, FL, ID, IL IA, MN, MO, PA, WI.    OUS: Mexico
Dexium (dexamethasone) Solution. Bimeda (1DEX022) and VetOne (1DEX032), NADA 200-312, 2mg/mL, packaged in 100 mL glass amber vial, Sterile. ANDA 200-312.    Each-ml. contains 2mg dexamethasone, 500 mg polyethylene glyco 400, 9 mg  benzyl alcohol, 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives, 4.75% alcohol, HCI to adjust pH to approximately 4.9, water  for injection q.s.  For intravenous or Intramuscular injection.  USUAL DOSE:  Bovine- 5 to 20 mg  equine- 2.5 to 5 mg
Bimeda Dexium (dexamethasone) Solution, Item# 1DEX022 and VetOne Dexamethasone Solution, Item# 1DEX032 are being recalled by Bimeda, Inc due that the product might contain particles that appear to be crystals.
Maquet Datascope Corp - Cardiac Assist Division
Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Labeling: Incorrect or Missing Lot and/or Exp Date
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg  DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
U.S. distribution to the following Trader Joe's distribution center locations; WA, CT, PA    No foreign distribution.
Trader Joe's Nuts   Raw Cashew Pieces  NET Wt. 18 oz (1 LB)   UPC Code: 0050 5154  Product of Thailand, Vietnam, & India  Packaged in Thailand
Heritage International USA, Inc. is recalling Trader Joe's Raw Cashew Pieces because of potential Salmonella contamination.
The S.C.O.R.E.S. Unit (self contained operating room equipment  sterilization unit)
Water retention issues.  Units with filters that remain wet after the sterilization may compromised sterility.
ALL distributed S.C.O.R.E.S. units are affected.
Blood products, which were not quarantined due to medical history, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed.
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
Department of Army US Army Blood Bank Center
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
18168-BLN	:	Brilliance Clear Premium Frying Oil 35 lb.	;  16763-MFY	:	Mel-Fry Essential High Performance Liquid Frying Oil 35 lb.	;  16502-MFY	:	Mel-Fry Premium High Performance Liquid Frying Oil 35 lb.	;
Ventura Foods is recalling various brands of cooking oil in 35 lb. jugs due to the presence of plastic. jug supplier reported that the manufacturing defect in the 35 lb. jugs was caused by the sealing surface trim possibly being pushed into the jug during the trimming process.
18168-BLN	:  16763-MFY	:  16502-MFY	:      And Julian day codes (DDY): 226 through 406
45532-CHP: Chef's Pride Soybean Clear Fry Oil 35 lb.;   54135-CHP: Chef's Pride Soybean Salad Oil 35 lb.;   45635-CHP: Chef's Pride Soybean Pan & Grill Frying Oil 35 lb.;   54135-TXR: Texas Roadhouse Soybean Salad Oil 35 lb.;   54135-PAD: Panda Express Soybean Salad Oil 35 lb.
18159-BLN	:	Brilliance Clear Zero Premium Clear Canola Frying Oil 35 lb.	;  58503-CHP	:	Chef's Pride Canola Clear Fry Oil 35 lb.	;  58503-FLV	:	Flavorite Canola Clear Fry Oil 35 lb.	;  58503-PLF	:	Planet Fry Canola Clear Fry Oil 35 lb.	;  58503-NGT	:	Nugget Brand Canola Clear Fry Oil 35 lb.	;
18159-BLN  58503-CHP  58503-FLV  58503-PLF  58503-NGT      And Julian day codes (DDY): 226 through 406
45532-ATL	:	Atlantic Food Distributors Premium Clear Liquid Fry Shortening 35 lb.	;  45531-ATL	:	Atlantic Food Distributors Premium Creamy Liquid Fry Shortening 35 lb.	;  45531-CHP	:	Chef's Pride Creamy Liquid Fry Shortening 35 lb.	;  45531-UBA	:	Creamy Liquid Fry Shortening 35 lb.	;  45532-FAR	:	Frosty Acres Restaurant's Pride Clear Liquid Fry Shortening 35 lb.	;  45531-GOL	:	Golbon Creamy Liquid Fry Shortening 35 lb.	;  45532-NIF	:	NIFDA Clear Liquid Shortening 35 lb.	;  45531-NIF	:	NIFDA Creamy Liquid Shortening 35 lb.	;  45532-NGT	:	Nugget Brand Clear Liquid Frying Shortening 35 lb.	;  45532-PLF	:	Planet Fry Clear Liquid Fry Shortening 35 lb.	;  45532-POC	:	Pocahontas Clear Fry Liquid Shortening 35 lb.	;  45532-SSC	:	Smart Source Clear Liquid Fry Shortening 35 lb.	;  45531-SSC	:	Smart Source Creamy Liquid Fry Shortening 35 lb.	;  90101-COM	:	Sysco Classic Clear Canola Frying Shortening ZTF 35 lb.	;  15172-COM	:	Sysco Fry-One ZTF Clear Canola/Corn Frying Shortening 35 lb.	;  99880-COM	:	Sysco Reliance Clear Soybean Frying Shortening ZTF 35 lb.	;  99947-COM	:	Sysco Reliance Creamy Soybean Frying Shortening ZTF 35 lb.	;  45531-TXR	:	Texas Roadhouse Trans Fat Free Liquid Fry Shortening 35 lb.	;
Blood product, with a low pH, was distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
US Distribution including Puerto Rico and to the states of :  DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use     To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
126 cases total (87 cases domestically and 39 cases internationally)
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA  610-435-4706, NDC 99999-9999-69 / 89999-9001-04
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only,  Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
U.S. distribution to the following; TX.  No foreign distribution.
H-E-B Tartar Sauce  8 oz.  UPC: 41220 33244
Fresh Creative Foods is recalling H-E-B Tartar Sauce because of undeclared fish from using the incorrect pre-printed label.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Florida, Iowa, Illinois, Maryland, Michigan, New York, Ohio, Pennsylvania, Virginia, Wisconsin, West Virginia
The firm was notified by one of their ingredient suppliers that an ingredient used to manufacture the recalled product may contain metal fragments.
Jack and the Green Sprouts, Alfalfa Sprouts, Net Wt 5 oz (142 g), UPC 7 6324719891 5      Retail:  5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.
Alfalfa Sprouts might be contaminated with E.coli 0157
Jack and the Green Sprouts, Alfalfa & Onion Sprouts, Net Wt 5 oz (142 g),  UPC 7 6324719594 5.      Retail:  5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.
Retail and foodservice establishments in the following states:   IA, IL, IN, KY, MI, MN, MO, NE, NV, OH, PA, TN, WI, WV
Fancy Fruit & Nut Mix   9-oz. retail plastic tub or 25-lb. bulk plastic bag.    12, 9-oz.  tubs per case.    1, 25-lb. bag per case.
90 Cases  464677 (25# Fancy Fruit & Nut Mix); 113 Cases  582164 (12-9oz Fancy Fruit & Nut Mix); 33 Cases  - 583524 (12-9oz. Private Label Fancy Fru
The pistachio products are being recalled as they have the potential to be contaminated with Salmonella.
Fancy Fruit & Nut Mix   Generic (packaged by JLM)    Product # 464677   25 Pound Bag UPC 094776129195  Lot numbers   12201508 best by 8/11/2016   01201509 best by 8/31/2016     Product # 582164  9 oz tub UPC 094776144594  Lot numbers  26201508 best by 8/25/2016   07201510 best by 10/6/2016   04201512 best by 12/3/2016   13201601 best by 1/12/2017     Fancy Fruit & Nut Mix  Private labeled (Blue Goose Market, Hollywood  Market, Market Fresh Fine Foods,  Market Square, Rogers Foodland,  Trentwood Farms)     Product # 583524  9 oz tub UPC 094776144594  Lot numbers  26201508 best by 8/25/2016   07201510 best by 10/6/2016   04201512 best by 12/3/2016   13201601 best by 1/12/2017
Pistachio Raw Whole Shelled  9-oz. retail plastic tub or 5-lb. bulk plastic bag.    12, 9-oz  tubs per case.    1, 5# bag per case.
U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
Papoose Infant Spine Immobilizer  Item #	Item Description:  PA-100	Papoose  PAR-100	Papoose w/replacement pads  PO-100	Papoose w/o PO front  POR-100	Papoose w/o PO front w/pad     Product Usage:  The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Item #	Item Description:  PA-100	Papoose  PAR-100	Papoose w/replacement pads  PO-100	Papoose w/o PO front  POR-100	Papoose w/o PO front w/pad     All lot numbers from MX140101 to MX150930
Extreme Custom    Product Usage:  Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Rebound Air Walker    Product Usage:  Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
Rebound Diabetic Walker    Product Usage:  Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
Rebound Cartilage Custom    Product Usage:  Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
Unloader Custom    Product Usage:  Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Unloader XT    Product Usage:  Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Unloader Custom Lite    Product  Usage:  Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Knee Shield (Patella Cup)    Product Usage:  Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
Miami J Collar    Product Usage:  Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
NecLoc Extrication Collar    Product Usage:  Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Item No.:  NL-200EL  NL-250E  NL-300E  NL-400E  NL-500E  NL-P1  NL-P2  NL-P3
Back Support Suspenders Clip on Black  Back Support Suspenders Sew on Black
Knee Undersleeve Gray    Product Usage:  Knee undersleeves are worn as an accessory for comfort under knee braces.
Rebound Cartilage    Product Usage:  Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
Molteno3 Glaucoma Implants G-Series:    GS-Single Plate 175mm2 (IOP reorder#: M3-175)  GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.
Distributed to retail stores in Illinois only.
Linda's Salsa Medium in 16 oz. glass jars
Products produced under insanitary conditions following a breach in security.
Linda's Black Bean and Corn Salsa in 16 oz. glass jars
Vanguard XP Knee System  Porous Femoral Component  various sizes and orientation a total knee replacement system.    prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous,  coated, polymer/metal/polymer
Part number; Description; Lot number    195929	Vanguard XP Porous Femoral Rt 52.5	055330  195929	Vanguard XP Porous Femoral Rt 52.5	105710  195929	Vanguard XP Porous Femoral Rt 52.5	105820  195929	Vanguard XP Porous Femoral Rt 52.5	273570  195929	Vanguard XP Porous Femoral Rt 52.5	727260  195929	Vanguard XP Porous Femoral Rt 52.5	727280  195930	Vanguard XP Porous Femoral Rt 55	054980  195930	Vanguard XP Porous Femoral Rt 55	727270  195930	Vanguard XP Porous Femoral Rt 55	727290  195930	Vanguard XP Porous Femoral Rt 55	727310  195930	Vanguard XP Porous Femoral Rt 55	886090  195930	Vanguard XP Porous Femoral Rt 55	961570  195930	Vanguard XP Porous Femoral Rt 55	961580  195931	Vanguard XP Porous Femoral Rt 57.5	054700  195931	Vanguard XP Porous Femoral Rt 57.5	054760  195931	Vanguard XP Porous Femoral Rt 57.5	054990  195931	Vanguard XP Porous Femoral Rt 57.5	055340  195931	Vanguard XP Porous Femoral Rt 57.5	105720  195931	Vanguard XP Porous Femoral Rt 57.5	105730  195931	Vanguard XP Porous Femoral Rt 57.5	105830  195931	Vanguard XP Porous Femoral Rt 57.5	624770  195931	Vanguard XP Porous Femoral Rt 57.5	624940  195932	Vanguard XP Porous Femoral Rt 60	054770  195932	Vanguard XP Porous Femoral Rt 60	054780  195932	Vanguard XP Porous Femoral Rt 60	055000  195932	Vanguard XP Porous Femoral Rt 60	055160  195932	Vanguard XP Porous Femoral Rt 60	105840  195932	Vanguard XP Porous Femoral Rt 60	519250  195932	Vanguard XP Porous Femoral Rt 60	624780  195932	Vanguard XP Porous Femoral Rt 60	624950  195932	Vanguard XP Porous Femoral Rt 60	624960  195932	Vanguard XP Porous Femoral Rt 60	961610  195932	Vanguard XP Porous Femoral Rt 60	961620  195932	Vanguard XP Porous Femoral Rt 60	996930  195933	Vanguard XP Porous Femoral Rt 62.5	054600  195933	Vanguard XP Porous Femoral Rt 62.5	054790  195933	Vanguard XP Porous Femoral Rt 62.5	055010  195933	Vanguard XP Porous Femoral Rt 62.5	055170  195933	Vanguard XP Porous Femoral Rt 62.5	055350  195933	Vanguard XP Porous Femoral Rt 62.5	105850  195933	Vanguard XP Porous Femoral Rt 62.5
Naturmed Inc DBA Institute for Vibrant Living
All Day Energy Greens (ADEG), Original Flavor, Net Wt 11.36 oz (322g), UPC Code 893320002096
NatureMed Inc. dba Institute for Vibrant Living is recalling All Day Energy Greens powdered green drink due to some reported cases of gastrointestinal distress.
All Day Energy Greens Fruity (ADEGF), Great Fruity Taste!, Net Wt 10.5 oz (299g), UPC Code 893320002096 and 893320002423.
Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).
Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.
P/N1400-1230 from Lot#2350871 from either loose inventory  or Kit 555000162, Date of Manufacture: April 16, 2013
US Nationwide Distribution including Puerto Rico.
Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant.  Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug.  If treatment with fulvestrant has been altered or discontinued as a result  of falsely elevated e
Part Number  Elecsys Estradiol II : 03000079190; all lot numbers are affected.
Elecsys Estradiol III: 06656021190; all lot numbers are affected.
Constantine Poulos and Company dba International Foods, Inc.
Product was distributed prior to February 11, 2016 in OH, MA, NH, NC, and ME
DELPHI GREEK PEPPERONCINI; Peppers, Water, Salt, Vinegar, Citric Acid, Sodium Benzoate.  INTERNATIONAL FOODS, INC. BURLINGTON, VT 05401 NET Weight 3 lb. 8 oz.   Product is stored at ambient temperature.
LOT# OCT 28 USE BY JUNE 30, 2016  LOT# 1120 USE BY JULY 30, 2016
Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41    Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026.    Japan:  10638819 LabPro v4.11 Software Update Kit  10638820 LabPro v4.11 System Software  10805072 LabPro MBT Non-Connect Systems v4.30  10805073 LabPro MBT Connect Systems v4.30  Canada:  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  Europe:  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software  USA:  10714149, LabPro v4.11 Software Update Kit  10714150 LabPro v4.11 System Software  10975000 ASM LabPro-MBT v4.40  10975001 ASM LabPro-MBT v4.40 for Connect  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  ROW:  6000-0008 LabPro v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software    Product Usage:  LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ
Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS BLUERAZZ NATURAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 3.7 OZ (105 GRAMS) packaged in red plastic jars with black lids.
Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.
Prosupps Dr. Jekyll INTENSE PUMP PRE WORKOUT, 30 SERVINGS, WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.1 OZ (315 GRAMS) packaged in red plastic jars with black lids.
Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 7.5 OZ (213 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 15.0 OZ (426 GRAMS) both packaged in red plastic jars with black lids.
Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS ORANGE BURST  NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 4.0 OZ (113 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS ORANGE BURST NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 7.9 OZ (225 GRAMS) both packaged in red plastic jars with black lids.
Prosupps Dr. Jekyll, INTENSE PUMP PRE WORKOUT, 30 SERVINGS, FRUIT PUNCH NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.4 OZ (324 GRAMS) packaged in red plastic jars with black lids.
U.S. distribution to the following; CA, FL, TX, IL, GA, NJ, MI, MA, PA, NY, NC, OH, MD, NM, SC, AL, TN, OK, MS, AZ, ME, VA, NV, WY, UT, AL.    No foreign distribution.
Nestle USA is recalling MAGGI Chicken Bouillon tablets because of undeclared wheat.
Production Codes: All Best Before ending in years 2015, 2016, 2017
Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Intrathecal Catheter kit.  We have identified that this kit may have been produced with incorrect outer package labels.  As a result, it may not contain all components necessary to complete the implant procedure.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Nationwide Distribution including New York, Texas, Florida, and Ohio
VERO (TM) MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator  MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
The foreign manufacturer became aware of a potential safety issue associated with the VERO/MHI-TM2000 Linear Accelerator System.  In rare cases it may happen that the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met.  If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is awar
Implant Direct Sybron Manufacturing, LLC
Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system.     GoDirect Implants  Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.
Pelton & Crane / Marus / DCI Equipment / KaVo
US Nationwide Distribution in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WI and Canada
Helios HL3T and HLT Track Mounted Dental Lights    Product Usage:  The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.
MD, TN, FL, NY & MN; Puerto Rico; Canada
Analyzer with Software Version 1.2.10, with a glitch, was distributed.
US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Model Number: SOMATOM Sensation Open - 8872017
Model Number: SOMATOM Sensation Cardic - 7543106
Model Number: SOMATOM Sensation 16 - 7393114
Model Number: SOMATOM Sensation 64/ Cardiac 64 - 8377520
Model Number: SOMATOM Emotion Duo (2003) - 3813933
Model Number # SOMATOM Emotion 6 - 3815490
Model Number: SOMATOM Emotion 16 - 7734713
Cheesy Pepper Jack Wrapped In A Battered Flour Tortilla For Institutional Use Only. Net Weight 4.5 lb 2 kg packaged in a cardboard box with black inkjet printing.
Plastic was found in a food product by a customer.
Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic,  Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong,  Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya,  Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia,  Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines,   Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore,  Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania,  Thailand, Turkey, United Arab Emirates and United Kingdom.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11.  Monitors subcutaneous ECG continuously.
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
US distribution to CA for further distribution within the US by own label distributor.
Wellco Super Elixir Pouches   The Super Elixir  150g, 300g
Healthy Solutions is recalling Super Elixir Pouches because of potential Salmonella contamination.
Product was shipped to the following states: AR, AZ, IL, IN & MI.
Favorites Natural Pistachios, roasted & salted, 4.5 oz (128g)  pouch UPC 0 38445 12286 5 Proudly distributed by Circle K Stores, Inc.  P.O. Box 52085 Phoenix, AZ 85072 www.circlek.com
The firm was notified by their  supplier that the product may contain Salmonella.
Worldwide Distribution - US Nationwide in the states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.***** Foreign Consignees: Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Palestinian Ter, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Tunisia, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay and  Vietnam.
The E.CAM gamma camera system     Product Usage:  The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002).  The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change
The Symbia gamma camera system     Product Usage:  The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Safe-T-Vue 10 and Safe-T-Vue 6  Temptime  116 The American Road  Morris Plains, NJ 07950  www.williamlabs.com
Updated Instructions for Use with revised storage instructions for some lots of Safe-T-Vue 6 and Safe-TuVue 10 was distributed.
Ortho Vision Analyzer for ID-Micro Typing System MTS Gel Cards  Ortho Clinical Diagnostics, Rx Only  Catalog #6904577    Labeling is Ortho Vision Analyzer ID-MTS Gel Cards Reference Guide
Urgent Product Correction Notification for the Ortho Vision Analyzers with Software version 2.12.13 and Below, was distributed.
Catalog Number:  6904577    Serial Numbers:  50002038-50002150
Blood products, exposed to unacceptable temperatures during storage, were distributed.
Blood product for which donor screener failed to ask donor Pre-Donation Health History questions, was distributed.
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA   NDC 55111-688-52
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.
CDI Blood Parameter Monitoring System 500  Cardiopulmonary bypass on-line blood gas monitor
Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX.    Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device     Product Usage:  Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.
18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices.  This can result in differences in scale orientation.
device model numbers: RT-4545CV-17, RT-4545CV-20
US Nationwide Distributed in the states of AR, CA, NE and UT
CIOS ALPHA (Image-intensified fluoroscope x-ray system)    Product Usage:  The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance.  The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.
US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959    Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage.  In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter.  As  a result there is the potential to deliver dose to the initial isocenter rather than the new location.
Model number: 10000  Catalog/Part Number: 10000  Serial Numbers: 100, 101, 102, 104 & 105
sold on  AK, AL, AZ, CA, FL, GA, ID, IN, MA, MN, NJ, NY, OR, UT, and WA and in Netherland. Products were sold from www.maryjanesfarm.org.
Thai Fusion Outpost, net weight 5.1 oz.  UPC 0 99853 34255 9.    Thai Fusion Bulk bag, packaged in a ziploc plastic bag, net weight 3 lbs. UPC 0 99853 35255 8.    Thai Fusion On the Go, packaged in microwave able paper cup with plastic lid, net wt. 3.4 oz. UPC 0 99853 38255 5.
15/5.1 oz. pouches of Outpost; 6/3.4 oz. cups of On the Go; and 12/3 lbs bags.
Organic Thai Fusion Outpost 5.1 oz. packages, Organic Thai Fusion 3 lbs. bulk bags, and  Organic On the Go Thai Fusion 3.4 oz cups are recalled due to undeclared milk.
Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet.  This leak can occur sporadically in affected systems.
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System.  The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi
Lot Number# 1776197 (5706588), 1782340 and 1868678  Catalog ID 03.120.027  For lot 1776197, the part is etched with 1776197; the package label documents 5706588.
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
Software issues on Cios Alpha mobile C-Arm system
Nationwide Distribution to Michigan only
Artis One, Interventional, Fluoroscopic, x-ray system  Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
AXIOM Artis zee/zeego, system, x-ray, angiographic    Product Usage:  AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet.  Loss of coolant can result in a cooling system failure and subsequent system failure.  This leak can occur sporadically in affected systems.