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
Nidek Inc
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management softwa...
Medical Devices·86 affected·Aug 1, 2013
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made...
Medical Devices·23 affected·Jul 26, 2013
High RiskFDA
Velocity Medical Solutions, Llc
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (phy...
Diagnostic Devices·54 affected·Jul 25, 2013
RecallCPSC
Authorized Hollis Dealers Nationwide From July 2011 Through May 2013 For About $500.
Hollis Recalls Digital Dive Computers Due to Drowning Hazard
Electronics·1,000 affected·Jul 11, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View...
Medical Devices·26 affected·Jul 10, 2013
High RiskFDA
Picis Inc.
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a d...
Medical Devices·35 affected·Jun 21, 2013
RecallFDA
Technidata S.a.
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Info...
Medical Devices·1 affected·Jun 20, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part ...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Accelerated Care Plus Corporation
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germa...
Medical Devices·1,001 affected·Jun 12, 2013
CriticalFDA
Respironics California Inc
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 105...
Respiratory Devices·19,200 affected·Jun 4, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5...
Diagnostic Devices·76 affected·Jun 3, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. ...
Diagnostic Devices·776 affected·May 20, 2013
RecallFDA
Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Medical Devices·329 affected·May 14, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Medical Devices·4 affected·May 7, 2013
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·45 affected·May 6, 2013
High RiskFDA
Hologic, Inc.
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provi...
Surgical Devices·287 affected·Apr 25, 2013
CriticalFDA
Brainlab Ag
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS Sys...
Medical Devices·2,528 affected·Apr 22, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body...
Medical Devices·2,348 affected·Apr 15, 2013
High RiskFDA
Alpine Biomed Aps
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A...
Medical Devices·871 affected·Apr 9, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ...
Medical Devices·245 affected·Apr 4, 2013
High RiskFDA
American Optisurgical Inc
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Surgical Devices·194 affected·Mar 30, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that meas...
Diagnostic Devices·490 affected·Mar 20, 2013
High RiskFDA
Agfa Corp.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured repo...
Cardiac Devices·2 affected·Mar 15, 2013
High RiskFDA
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·5 affected·Mar 12, 2013
High RiskFDA
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·Mar 12, 2013
High RiskFDA
Hospira Inc.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-ad...
Medical Devices·8,794 affected·Mar 8, 2013
High RiskFDA
Maquet Cardiovascular, Llc
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxyg...
Respiratory Devices·154 affected·Mar 7, 2013
CriticalFDA
Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and pow...
Medical Devices·9,241 affected·Mar 6, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedu...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use dur...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedure...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended f...
Respiratory Devices·3,972 affected·Feb 27, 2013
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Co...
Medical Devices·180 affected·Feb 15, 2013
High RiskFDA
Raysearch Laboratories Ab
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy T...
Medical Devices·70 affected·Feb 15, 2013