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
Syngo Imaging VB36D_HF02. Radiological image processing system.
Medical Devices·3 affected·Oct 28, 2015
High RiskFDA
Carl Zeiss Meditec Ag
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measuremen...
Medical Devices·1,882 affected·Oct 27, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiol...
Cardiac Devices·2 affected·Oct 26, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio with software version 10.1 LA.
Medical Devices·1 affected·Oct 26, 2015
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Medical Devices·9 affected·Oct 15, 2015
High RiskFDA
Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Medical Devices·27 affected·Oct 7, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine,...
Medical Devices·87 affected·Oct 7, 2015
High RiskFDA
Varian Medical Systems, Inc.
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA ...
Medical Devices·1,971 affected·Sep 28, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·16 affected·Sep 22, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive ...
Medical Devices·89 affected·Sep 22, 2015
High RiskFDA
Natus Neurology Inc
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without sy...
Diagnostic Devices·101 affected·Sep 11, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Philips Healthcare
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Medical Devices·423 affected·Sep 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON ...
Cardiac Devices·4 affected·Sep 5, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gase...
Respiratory Devices·30 affected·Sep 3, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions wi...
Diagnostic Devices·449 affected·Aug 26, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging ...
Cardiac Devices·2,039 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Medical Devices·21 affected·Aug 18, 2015
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Medical Devices·4 affected·Aug 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fro...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from ...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and ...
Respiratory Devices·4,638 affected·Aug 7, 2015
High RiskFDA
Bayer Healthcare
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically fo...
Medical Devices·71 affected·Aug 4, 2015
High RiskFDA
Bd Life Sciences
Software version 4.44A utilized on the BD MAX System
Medical Devices·29 affected·Jul 29, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Medical Devices·35 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Medical Devices·4 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Medical Devices·8 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·1 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·5 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
Medical Devices·6 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·2 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Medical Devices·6 affected·Jul 27, 2015
High RiskFDA
Nordicneurolab As
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to ...
Respiratory Devices·121 affected·Jul 3, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·44 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·13 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomo...
Diagnostic Devices·2 affected·Jul 1, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemi...
Diagnostic Devices·6,801,375 affected·Jun 30, 2015
High RiskFDA
Biotronik, Inc.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK...
Cardiac Devices·768 affected·Jun 30, 2015
RecallFDA
Getinge Disinfection Ab
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and lab...
Medical Devices·20 affected·Jun 26, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10...
Cardiac Devices·1,789 affected·Jun 25, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Nidek Inc
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.0...
Diagnostic Devices·3,836 affected·Jun 15, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified...
Cardiac Devices·13,168 affected·Jun 5, 2015