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
Nihon Kohden America Inc
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple pat...
Cardiac Devices·430 affected·Jun 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solution...
Medical Devices·790 affected·Jun 3, 2014
High RiskFDA
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 3...
Medical Devices·224 affected·May 29, 2014
High RiskFDA
Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Medical Devices·42,600 affected·May 22, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices·17 affected·May 21, 2014
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with t...
Medical Devices·64 affected·May 8, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accele...
Medical Devices·108 affected·May 6, 2014
High RiskFDA
Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnost...
Diagnostic Devices·317 affected·May 5, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, ret...
Medical Devices·659 affected·May 5, 2014
High RiskFDA
Agfa Corp.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creat...
Diagnostic Devices·0 affected·Apr 30, 2014
CriticalFDA
Hamilton Medical, Inc.
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for inten...
Respiratory Devices·1,128 affected·Apr 22, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety...
Diagnostic Devices·6 affected·Apr 17, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]....
Cardiac Devices·101 affected·Apr 7, 2014
High RiskFDA
Boston Scientific Corporation
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Medical Devices·9 affected·Apr 3, 2014
High RiskFDA
Ge Healthcare
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based ...
Respiratory Devices·723 affected·Apr 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic extern...
Cardiac Devices·9,872 affected·Apr 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, dist...
Medical Devices·373 affected·Apr 2, 2014
High RiskFDA
United Therapeutics Corp.
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured f...
Oral Drugs·188 affected·Mar 28, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantit...
Diagnostic Devices·20 affected·Mar 20, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips M...
Diagnostic Devices·157 affected·Mar 11, 2014
CriticalFDA
Del Mar Reynolds Medical, Ltd.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Respiratory Devices·16 affected·Mar 10, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Medical Devices·116 affected·Mar 6, 2014
High RiskFDA
Bio-rad Laboratories, Inc.
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercu...
Diagnostic Devices·483 affected·Feb 27, 2014
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this corre...
Medical Devices·15 affected·Feb 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 ser...
Cardiac Devices·33 affected·Feb 14, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrum...
Surgical Devices·21 affected·Feb 14, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Medical Devices·251 affected·Feb 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feat...
Cardiac Devices·10,211 affected·Feb 13, 2014
High RiskFDA
Biosense Webster, Inc.
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC ...
Surgical Devices·8 affected·Feb 12, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Medical Devices·19 affected·Feb 6, 2014
High RiskFDA
Clarity Medical Systems Inc
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmi...
Medical Devices·166 affected·Jan 24, 2014
High RiskFDA
Accuray Incorporated
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided ...
Medical Devices·302 affected·Jan 13, 2014
High RiskFDA
Veridex, Llc
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope,...
Diagnostic Devices·19 affected·Jan 8, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor inten...
Cardiac Devices·40,239 affected·Dec 27, 2013
High RiskFDA
Eos Imaging
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstati...
Medical Devices·36 affected·Nov 29, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·300 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined tar...
Medical Devices·1,309 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Medical Devices·455 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·134 affected·Nov 25, 2013
High RiskFDA
Varian Medical Systems, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuit...
Medical Devices·6,701 affected·Nov 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Medical Devices·147 affected·Nov 15, 2013
High RiskFDA
Nobel Biocare Usa Llc
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set O...
Medical Implants·1,082 affected·Oct 24, 2013
High RiskFDA
Vital Images, Inc.
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as ...
Diagnostic Devices·598 affected·Oct 21, 2013
High RiskFDA
Philips Medical Systems North America Inc.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Diagnostic Devices·306 affected·Oct 17, 2013
High RiskFDA
Philips Healthcare Informatics, Inc.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardwa...
Medical Devices·71 affected·Oct 14, 2013
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a dispo...
Medical Devices·6,380 affected·Oct 10, 2013
High RiskFDA
Neurotherm, Inc.
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Medical Devices·25 affected·Oct 9, 2013