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
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectio...
Medical Devices·1,096 affected·Mar 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha, mobile X-ray system
Medical Devices·89 affected·Feb 19, 2016
High RiskFDA
Medtronic Minimed Inc.
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of contin...
Diabetes Devices·20 affected·Feb 19, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Medical Devices·116 affected·Feb 9, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction o...
Medical Devices·49 affected·Feb 5, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-r...
Medical Devices·82 affected·Feb 5, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-...
Medical Devices·285 affected·Feb 5, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction ...
Medical Devices·174 affected·Feb 5, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·88 affected·Feb 5, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X...
Medical Devices·324 affected·Feb 5, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimension...
Medical Devices·49 affected·Feb 5, 2016
CriticalFDA
Draeger Medical, Inc.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Respiratory Devices·2,553 affected·Feb 4, 2016
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·25 affected·Jan 31, 2016
High RiskFDA
Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·844 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate c...
Medical Devices·324 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional an...
Medical Devices·109 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, ...
Medical Devices·151 affected·Jan 29, 2016
High RiskFDA
Physio-control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software versio...
Cardiac Devices·44,798 affected·Jan 27, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery ...
Medical Devices·226 affected·Jan 22, 2016
High RiskFDA
Vital Scientific N.v.
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer,...
Diagnostic Devices·2 affected·Jan 18, 2016
High RiskFDA
Philips Respironics
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus prov...
Respiratory Devices·104,508 affected·Jan 18, 2016
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Medical Devices·5,000 affected·Jan 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, di...
Medical Devices·68 affected·Dec 22, 2015
High RiskFDA
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions an...
Medical Devices·25 affected·Dec 15, 2015
High RiskFDA
Ascom Us, Inc.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Medical Devices·319 affected·Dec 10, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quan...
Diagnostic Devices·834 affected·Dec 1, 2015
CriticalFDA
Draeger Medical, Inc.
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit inten...
Respiratory Devices·2,422 affected·Dec 1, 2015
High RiskFDA
Zyto Technologies, Inc.
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the se...
Medical Devices·1,252 affected·Nov 23, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Medical Devices·42 affected·Nov 17, 2015
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an...
Medical Devices·56 affected·Nov 11, 2015
High RiskFDA
Shimadzu Medical Systems
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general...
Medical Devices·297 affected·Nov 10, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·51 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfa...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD...
Diagnostic Devices·157 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Soft...
Diagnostic Devices·200 affected·Nov 3, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices·323 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Computed Tomography X-ray system
Medical Devices·31 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Medical Devices·51 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·177 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices·7 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices·133 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray system
Medical Devices·135 affected·Oct 29, 2015