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
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 ...
Medical Implants·45,411 affected·Apr 6, 2021
High RiskFDA
Soft Computer Consultants, Inc.
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecul...
Medical Devices·1 affected·Mar 31, 2021
RecallFDA
Datascope Corp.
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left vent...
Medical Devices·10,087 affected·Mar 22, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a...
Diagnostic Devices·133 affected·Mar 19, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer
Medical Devices·28 affected·Mar 17, 2021
High RiskFDA
Medtronic Minimed
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 67...
Diabetes Devices·1,266 affected·Mar 15, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·195 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·43 affected·Mar 5, 2021
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems ...
Medical Devices·4,463 affected·Mar 1, 2021
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for...
Medical Devices·243 affected·Feb 26, 2021
High RiskFDA
Philips North America Llc
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for mon...
Medical Devices·3 affected·Feb 2, 2021
High RiskFDA
Thermo Fisher Scientific
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Medical Devices·19 affected·Feb 1, 2021
High RiskFDA
Biomerieux Inc
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test,...
Medical Implants·6,777 affected·Jan 28, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supportin...
Surgical Devices·37 affected·Jan 27, 2021
RecallFDA
Biomeme, Inc.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infe...
Diagnostic Devices·147 affected·Jan 5, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for ...
Diagnostic Devices·41 affected·Dec 18, 2020
High RiskFDA
Brainreader Aps
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, ...
Medical Devices·43 affected·Dec 14, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: inte...
Medical Devices·81 affected·Dec 10, 2020
High RiskFDA
Carl Zeiss Meditec Ag
IOLMaster 700
Medical Devices·613 affected·Dec 7, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administ...
Medical Devices·9,353 affected·Nov 23, 2020
High RiskFDA
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Medical Devices·27 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administ...
Medical Devices·140,006 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of...
Medical Devices·112,463 affected·Nov 23, 2020
High RiskFDA
Haag-streit Usa Inc
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes ...
Surgical Devices·3 affected·Nov 20, 2020
High RiskFDA
Medtronic Neuromodulation
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation ther...
Medical Implants·12 affected·Nov 19, 2020
High RiskFDA
Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucle...
Diagnostic Devices·597 affected·Nov 19, 2020
High RiskFDA
Philips North America, Llc
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for de...
Medical Devices·2,714 affected·Nov 19, 2020
High RiskFDA
Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes ...
Diabetes Devices·46,461 affected·Nov 12, 2020
High RiskFDA
Medtronic Neuromodulation
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended fo...
Medical Implants·7,960 affected·Nov 12, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Medical Devices·3 affected·Nov 11, 2020
High RiskFDA
Icu Medical, Inc.
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac out...
Cardiac Devices·220 affected·Nov 9, 2020
High RiskFDA
Kowa Optimed Inc
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicat...
Medical Devices·0 affected·Nov 3, 2020
High RiskFDA
Philips Ultrasound Inc
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Af...
Diagnostic Devices·57,430 affected·Oct 27, 2020
High RiskFDA
Biomeme, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplificat...
Respiratory Devices·105 affected·Oct 23, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configu...
Medical Devices·40 affected·Oct 9, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1,...
Medical Devices·2,768 affected·Oct 8, 2020
High RiskFDA
Livanova Usa Inc
VNS Therapy¿ AspireSR¿ Generator
Medical Devices·134 affected·Sep 28, 2020
High RiskFDA
Pentax Of America Inc
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Medical Devices·39 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Medical Devices·8 affected·Sep 22, 2020
High RiskFDA
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Respiratory Devices·212 affected·Sep 14, 2020
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or ex...
Medical Devices·1 affected·Sep 11, 2020
RecallFDA
Devicor Medical Products Inc
Neoprobe GDS Control Unit, Model Number NPCU3
Medical Devices·49 affected·Sep 7, 2020
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices·271 affected·Aug 31, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-29...
Diagnostic Devices·2 affected·Aug 7, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-29...
Diagnostic Devices·10 affected·Aug 7, 2020
High RiskFDA
Life Technologies Corporation
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time...
Respiratory Devices·0 affected·Aug 6, 2020
High RiskFDA
C-rad Positioning Ab
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Medical Devices·7 affected·Aug 6, 2020
High RiskFDA
Raysearch Laboratories Ab
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, plann...
Medical Devices·0 affected·Jul 29, 2020