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
Nox Medical
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Medical Devices·128 affected·Sep 7, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Medical Devices·298 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Medical Devices·665 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Medical Devices·232 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom sys...
Medical Devices·31 affected·Aug 18, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo Universal, Product number DS2000X11B
Medical Devices·10,000 affected·Jul 26, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15...
Medical Devices·101 affected·Jul 26, 2021
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Diagnostic Devices·4,833 affected·Jul 26, 2021
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Medical Devices·326 affected·Jul 23, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Medical Devices·26 affected·Jul 20, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Medical Devices·16 affected·Jul 20, 2021
High RiskFDA
Abbott Laboratories, Inc
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasm...
Diagnostic Devices·260 affected·Jul 12, 2021
CriticalFDA
Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Medical Devices·61 affected·Jul 7, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q flo...
Diagnostic Devices·70 affected·Jun 30, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Medical Devices·2,058 affected·Jun 24, 2021
High RiskFDA
Biomerieux Sa
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, ...
Medical Devices·248 affected·Jun 22, 2021
High RiskFDA
Wom World Of Medicine Ag
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Medical Devices·1,100 affected·Jun 18, 2021
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ven...
Respiratory Devices·60 affected·Jun 18, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Medical Devices·3,665 affected·Jun 14, 2021
High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·3,370 affected·Jun 7, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·812 affected·Jun 7, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating s...
Surgical Devices·4 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/eva...
Surgical Devices·6 affected·Jun 4, 2021
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Medical Devices·130,135 affected·Jun 4, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Diagnostic Devices·116 affected·May 27, 2021
CriticalFDA
Vero Biotech, Llc
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Medical Devices·465 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
ProxiDiagnost N90. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs ...
Diagnostic Devices·842 affected·May 18, 2021
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients ...
Medical Devices·22 affected·May 14, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a compu...
Cardiac Devices·9 affected·May 5, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Medical Devices·8 affected·May 5, 2021
High RiskFDA
Viewray, Inc.
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irrad...
Medical Devices·8 affected·May 4, 2021
High RiskFDA
Randox Laboratories Ltd.
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Medical Devices·50 affected·Apr 28, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM a...
Medical Devices·33 affected·Apr 19, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·2 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·34 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·18 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·12 affected·Apr 16, 2021
High RiskFDA
Haag-streit Usa Inc
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Medical Devices·0 affected·Apr 15, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some servic...
Medical Devices·0 affected·Apr 7, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medical Implants·16,311 affected·Apr 6, 2021