Medical DeviceFeb 1, 2017
Philips Electronics Velara Generator with an old Firmware version used with the Philips recall — FDA Z-1062-2017
System may lock up.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Latest records
Latest recalls — page 1703
The newest recall records with useful source details are listed here.
Medical DeviceFeb 1, 2017
Villa Radiology Systems Juno DRF; Model: 709020 Multi-function x-ray systems capable of recall — FDA Z-1063-2017
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a…
Class IIFDA: OngoingVilla Radiology Systems LLC
Medical DeviceFeb 1, 2017
Soft Computer Consultants Softbank software Product Usage: Decision support software for recall — FDA Z-1098-2017
Software error. Potential for incorrect results
Class IIFDA: TerminatedSoft Computer Consultants, Inc.
Medical DeviceFeb 1, 2017
Philips Electronics Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and recall — FDA Z-0924-2017
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceFeb 1, 2017
Hitachi Oasis MRI System - C-Spine Coil recall — FDA Z-1096-2017
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Class IIFDA: TerminatedHitachi Medical Systems America Inc.
Medical DeviceFeb 1, 2017
The Binding Site Group MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is recall — FDA Z-1073-2017
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceFeb 1, 2017
The Binding Site Group Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera recall — FDA Z-1070-2017
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceFeb 1, 2017
The Binding Site Group Human lgG4 Subclass kit for use on the Beckman Coulter AU" series recall — FDA Z-1068-2017
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceFeb 1, 2017
Merge Hemo software recall — FDA Z-1091-2017
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceFeb 1, 2017
Villa Radiology Systems Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231 recall — FDA Z-1064-2017
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a…
Class IIFDA: OngoingVilla Radiology Systems LLC
Medical DeviceFeb 1, 2017
INO Therapeutics Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system recall — FDA Z-1076-2017
Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an…
Class IIFDA: TerminatedINO Therapeutics (dba Ikaria)
Medical DeviceFeb 1, 2017
GE OEC Medical Systems OEC 9900 Elite. MDL Numbers: D148942, D155043 recall — FDA Z-1060-2017
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced…
Class IIFDA: TerminatedGE OEC Medical Systems, Inc.
Medical DeviceFeb 1, 2017
Roche Diagnostics Operations Tina-Quant (Latex) HS Test System recall — FDA Z-1092-2017
Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceFeb 1, 2017
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line recall — FDA Z-1080-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Soft Computer Consultants SCC Soft Computer Softbank II software Product Usage: Supports recall — FDA Z-1097-2017
Software error. Potential for incorrect results
Class IIFDA: TerminatedSoft Computer Consultants, Inc.
Medical DeviceFeb 1, 2017
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection recall — FDA Z-1087-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
FoodFeb 1, 2017
Victory General Foods ELDER PAINTSIL'S FANTE KENKEY, NET WT recall — FDA F-1336-2017
Product manufactured under insanitary conditions and firm did not follow the Food Code-mandated scheduled process
Class IIFDA: TerminatedVictory General Foods Inc.
FoodFeb 1, 2017
Coca-Cola Consolidated Dr recall — FDA F-1344-2017
Product labeled Dr. Pepper may instead contain Diet Dr. Pepper (containing undeclared Aspartame as a sweetener).
Class IIIFDA: TerminatedCoca-Cola Consolidated
FoodFeb 1, 2017
Berner Food & Beverage Four Cheese Alfredo, Pasta Sauce recall — FDA F-1358-2017
Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
Class IIFDA: TerminatedBerner Food & Beverage, LLC
FoodFeb 1, 2017
Authentic Alaska Alaska Salmon Bites recall — FDA F-1334-2017
Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor is recalled due to undeclared soy. Product contains undeclared soy sauce from the ingredient Tamari sauce.
Class IIFDA: TerminatedAuthentic Alaska
FoodFeb 1, 2017
Boulder Brands Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6oz recall — FDA F-1361-2017
Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
Class IFDA: TerminatedBoulder Brands, LLC
FoodFeb 1, 2017
Farm to Market Foods Green Bean Casserole Code #1958 Net Wt recall — FDA F-1340-2017
Undeclared peanuts.
Class IIFDA: TerminatedFarm To Market Foods
FoodFeb 1, 2017
Tortillas Tita 18 Count-16 Oz./453 g 16 units per case, 10 Count- 8 Oz./283 g recall — FDA F-1354-2017
Tortillas Tita initiated a voluntary recall of all lots of their Corn Tortillas and Tortilla Enchilada produced between September 2016 and December 7, 2016, due to undeclared allergen Wheat.
Class IIFDA: TerminatedTortillas Tita, LLC
FoodFeb 1, 2017
Boulder Brands Earth Balance Vegan Cheddar flavored Mac and Cheese, 6oz recall — FDA F-1362-2017
Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
Class IFDA: TerminatedBoulder Brands, LLC
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