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
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 15kw 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
Imaging Sciences International, Llc
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Medical Devices·366 affected·Jul 30, 2012
High RiskFDA
Cisco Systems Inc
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Syste...
Medical Devices·1 affected·Jul 23, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Medical Devices·126 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various...
Diagnostic Devices·13 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic aci...
Diagnostic Devices·3,772 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (...
Medical Devices·1,213 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isola...
Medical Devices·816 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument syst...
Medical Devices·1,015 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ T...
Diagnostic Devices·884 affected·Jul 16, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is ...
Cardiac Devices·476 affected·Jul 11, 2012
High RiskFDA
Ge Healthcare, Llc
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·254 affected·Jul 10, 2012
High RiskFDA
Radiometer America Inc
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Medical Devices·1,427 affected·Jul 5, 2012
High RiskFDA
Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of w...
Medical Devices·6,854 affected·Jul 5, 2012
High RiskFDA
Merge Healthcare, Inc.
Merge HEMO software.
Medical Devices·37 affected·Jul 2, 2012
High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD F...
Diagnostic Devices·96 affected·Jun 29, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW ap...
Medical Devices·429 affected·Jun 28, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Medical Devices·15 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic inte...
Medical Devices·226 affected·Jun 14, 2012
High RiskFDA
Ge Healthcare, Llc
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or ...
Medical Devices·70 affected·May 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client application...
Diagnostic Devices·38 affected·May 23, 2012
High RiskFDA
Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of to...
Medical Devices·137,445 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+...
Medical Devices·146 affected·May 22, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variet...
Medical Devices·1,387 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety...
Medical Devices·77 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of anal...
Medical Devices·2,044 affected·May 21, 2012
CriticalFDA
Natus Medical Incorporated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-i...
Medical Devices·324 affected·May 9, 2012
High RiskFDA
Raysearch Laboratories Ab
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Produ...
Medical Devices·19 affected·May 9, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer re...
Medical Devices·241 affected·May 7, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be use...
Medical Devices·1,292 affected·Apr 23, 2012
RecallFDA
Sigma
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and e...
Medical Devices·2,048 affected·Apr 23, 2012
High RiskFDA
Beckman Coulter Inc.
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and pos...
Medical Devices·468 affected·Apr 11, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Medical Devices·318 affected·Mar 27, 2012
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is ...
Medical Devices·126 affected·Mar 15, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza. Radiological image processing system
Medical Devices·2 affected·Feb 24, 2012
High RiskFDA
Hospira Inc.
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusi...
Medical Devices·1 affected·Feb 5, 2012
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System ...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456;...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Raysearch Laboratories Ab
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial na...
Medical Devices·20 affected·Oct 10, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Medical Devices·636 affected·Jul 20, 2011
High RiskFDA
Raysearch Laboratories Ab
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using i...
Medical Devices·15 affected·May 30, 2011
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network trans...
Medical Devices·0 affected·May 12, 2011
High RiskFDA
Ge Healthcare, Llc
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of th...
Cardiac Devices·244 affected·Apr 5, 2011
High RiskFDA
Philips Electronics North America Corporation
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, ...
Medical Devices·607 affected·Dec 17, 2010
High RiskFDA
Sendx Medical Inc
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyze...
Diabetes Devices·767 affected·Jan 6, 2010
Medium RiskCPSC
Directly To Consumers Through Targeted National Advertisements And Publications, Electronics And Drug Stores Nationwide, And On The Web At Www.jitterbug.com From March 2008 Through May 2009 For About $150.
Samsung Recalls to Upgrade Certain Cell Phones; Could Fail to Reach Emergency 911 in a No-Service Area
Electronics·160,000 affected·May 22, 2009
RecallFDA
Sunquest Information Systems, Inc.
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Medical Devices·23 affected·Apr 13, 2009
RecallCPSC
Various Cellular Dealers In Alabama, Alaska, Idaho, Kentucky, Mississippi, Puerto Rico, Tennessee, Washington State And Wisconsin From September 2008 Through November 2008 For About $200.
Certain LG 830 "Spyder" Cell Phones Recalled For Upgrade Due to Dropped Connection or Poor Connection on Emergency 911 Calls
Electronics·30,000 affected·Feb 27, 2009