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
Boston Scientific Corporation
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the ampl...
Medical Devices·43 affected·Jun 2, 2015
High RiskFDA
Merge Healthcare, Inc.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Medical Devices·341 affected·May 31, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: Th...
Cardiac Devices·573 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector opt...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microp...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate rea...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injecto...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Ptw-freiburg
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic rad...
Diagnostic Devices·242 affected·May 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab aut...
Medical Devices·1,941 affected·May 19, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitori...
Medical Devices·63 affected·May 13, 2015
High RiskFDA
Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiother...
Medical Devices·3 affected·May 7, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and pos...
Medical Devices·1,355 affected·Apr 29, 2015
High RiskFDA
Philips Medical Systems, Inc.
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professiona...
Medical Devices·4 affected·Apr 23, 2015
High RiskFDA
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Medical Devices·11 affected·Apr 17, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Medical Devices·105 affected·Apr 14, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·105 affected·Apr 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic...
Diagnostic Devices·133 affected·Apr 13, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital...
Medical Devices·133 affected·Apr 13, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite software. Radiological image processing system.
Medical Devices·10 affected·Apr 9, 2015
High RiskFDA
Baxter Corporation Englewood
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-base...
Medical Devices·882 affected·Apr 8, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management f...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample ...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management fo...
Diagnostic Devices·255 affected·Apr 6, 2015
High RiskFDA
Viewray Incorporated
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy...
Medical Devices·3 affected·Apr 1, 2015
High RiskFDA
Hamilton Medical, Inc.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ...
Respiratory Devices·248 affected·Mar 24, 2015
High RiskFDA
Sedecal Usa, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
Diagnostic Devices·145 affected·Mar 23, 2015
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01....
Medical Devices·4 affected·Mar 12, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T...
Medical Devices·9,369 affected·Mar 9, 2015
High RiskFDA
Brainlab Ag
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for st...
Medical Devices·25 affected·Mar 6, 2015
High RiskFDA
Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Medical Devices·13 affected·Mar 6, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge LIS software.
Medical Devices·413 affected·Mar 5, 2015
High RiskFDA
Raysearch Laboratories Ab
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RaySta...
Medical Devices·245 affected·Mar 4, 2015
High RiskFDA
Baxter Healthcare Corp
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Prod...
Medical Devices·58 affected·Mar 2, 2015
High RiskFDA
Optimedica Corporation
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Ca...
Medical Devices·171 affected·Feb 20, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: T...
Medical Devices·12 affected·Feb 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Inge...
Medical Devices·424 affected·Feb 5, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synaps...
Medical Devices·30 affected·Feb 4, 2015
High RiskFDA
Terarecon, Inc.
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow ...
Medical Devices·91 affected·Jan 21, 2015
High RiskFDA
Icad, Inc.
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Medical Devices·153 affected·Jan 21, 2015
High RiskFDA
Ino Therapeutics (dba Ikaria)
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Respiratory Devices·45 affected·Jan 14, 2015
High RiskFDA
Natus Medical Incorporated
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography ...
Medical Devices·248 affected·Jan 2, 2015
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage inf...
Medical Devices·9 affected·Dec 19, 2014
High RiskFDA
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Medical Devices·257,456 affected·Dec 18, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software ...
Medical Devices·7 affected·Dec 16, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic syst...
Diagnostic Devices·11 affected·Dec 15, 2014
High RiskFDA
Carestream Health Inc
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) ---...
Diagnostic Devices·629 affected·Nov 25, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Medical Devices·210 affected·Nov 21, 2014
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices·1,412 affected·Nov 19, 2014