Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of device...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devic...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operat...
Surgical Devices·53 affected·Feb 5, 2013
High RiskFDA
Vital Images, Inc.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and ...
Diagnostic Devices·7,649 affected·Feb 5, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and ca...
Medical Devices·179 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·21,551 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·7,692 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used f...
Medical Devices·1 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·214 affected·Feb 1, 2013
High RiskFDA
Hitachi Medical Systems America Inc
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imagi...
Medical Devices·45 affected·Jan 31, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS sys...
Medical Devices·5 affected·Jan 17, 2013
High RiskFDA
Envoy Medical Corporation
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA an...
Medical Implants·44 affected·Jan 9, 2013
High RiskFDA
Veridex, Llc
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose labo...
Diagnostic Devices·82 affected·Dec 28, 2012
High RiskFDA
Nordicneurolab As
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but ...
Medical Devices·36 affected·Dec 21, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sys...
Diagnostic Devices·1 affected·Dec 20, 2012
High RiskFDA
Intel-ge Care Innovations Llc
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' move...
Medical Devices·19 affected·Dec 16, 2012
High RiskFDA
Abbott Molecular
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecula...
Medical Devices·215 affected·Dec 4, 2012
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, an...
Diabetes Devices·28 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Medical Devices·896 affected·Nov 27, 2012
High RiskFDA
Ge Healthcare It
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support...
Medical Devices·17 affected·Nov 20, 2012
RecallFDA
Ge Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities a...
Medical Devices·7 affected·Nov 20, 2012
High RiskFDA
Ge Healthcare It
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators...
Medical Devices·1,379 affected·Nov 16, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Medical Devices·1 affected·Nov 14, 2012
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides w...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethern...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital...
Diagnostic Devices·551 affected·Oct 25, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography ...
Medical Devices·765 affected·Oct 24, 2012
High RiskFDA
Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator ...
Medical Devices·21 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray...
Medical Devices·39 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scannin...
Diagnostic Devices·37 affected·Oct 24, 2012
High RiskFDA
The Binding Site Group, Ltd.
Digital RID Plate Reader and Software Product Code: AD400
Medical Devices·0 affected·Oct 9, 2012
High RiskFDA
Ge Healthcare It
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold...
Cardiac Devices·1 affected·Oct 2, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW)...
Medical Devices·2,580 affected·Sep 28, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Diabetes Devices·1,600 affected·Sep 21, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·364 affected·Sep 20, 2012
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Medical Devices·10 affected·Sep 20, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging S...
Surgical Devices·46 affected·Sep 14, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging Sys...
Surgical Devices·414 affected·Sep 14, 2012
High RiskFDA
Beckman Coulter Inc.
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, comput...
Medical Devices·7 affected·Sep 3, 2012
RecallFDA
Philips Medical Systems (cleveland) Inc
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cro...
Medical Devices·93 affected·Aug 28, 2012
High RiskFDA
Volcano Corporation
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607...
Medical Devices·1,020 affected·Aug 24, 2012
High RiskFDA
Elekta, Inc.
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension...
Medical Devices·52 affected·Aug 21, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121...
Diagnostic Devices·240 affected·Aug 16, 2012
High RiskFDA
Zoll Medical Corporation
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of co...
Cardiac Devices·11 affected·Aug 16, 2012
High RiskFDA
Vital Images, Inc.
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 ...
Cardiac Devices·2,088 affected·Aug 13, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Op...
Diagnostic Devices·217 affected·Aug 1, 2012