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
Philips Medical Systems Nederlands
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Medical Devices·229 affected·Nov 30, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Medical Devices·643 affected·Nov 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 4535644...
Medical Devices·651 affected·Nov 15, 2018
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Medical Devices·5 affected·Nov 13, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, S...
Medical Devices·508 affected·Nov 9, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clin...
Medical Devices·1,105 affected·Oct 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes...
Diagnostic Devices·682 affected·Oct 19, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000...
Medical Devices·20,884 affected·Oct 15, 2018
CriticalFDA
Synaptive Medical Inc
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-...
Medical Devices·37 affected·Oct 9, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink Encore 29901 Programmer
Medical Devices·4,072 affected·Oct 2, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
C3 Wave App, v. 2.0.5
Medical Devices·24 affected·Oct 1, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: Th...
Diagnostic Devices·490 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The...
Diagnostic Devices·217 affected·Sep 26, 2018
High RiskFDA
Accuray Incorporated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic ra...
Medical Devices·93 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component...
Diagnostic Devices·264 affected·Sep 26, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Medical Devices·110 affected·Sep 21, 2018
High RiskFDA
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Medical Devices·354 affected·Sep 18, 2018
High RiskFDA
Beckman Coulter Inc.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpe...
Medical Devices·41 affected·Sep 17, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI700020...
Medical Devices·641 affected·Sep 17, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Medical Devices·152 affected·Sep 13, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imagin...
Cardiac Devices·61 affected·Sep 4, 2018
CriticalFDA
Alpha Omega Engineering
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelec...
Surgical Devices·29 affected·Sep 4, 2018
High RiskFDA
Accuray Incorporated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Medical Devices·259 affected·Aug 31, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018
CriticalFDA
Data Innovations, Llc
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer...
Medical Devices·9 affected·Aug 29, 2018
High RiskFDA
Hitachi Healthcare Americas Corp Informatics Division
VidiStar(TM) PACS & DICOM Viewer Software system
Medical Devices·12 affected·Aug 28, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·10,919 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·2,538 affected·Aug 13, 2018
High RiskFDA
Invivo Corporation
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Medical Devices·38 affected·Aug 3, 2018
High RiskFDA
Mobius Imaging, Llc
AIRO Mobile CT System Model # MobiCT-32
Medical Devices·147 affected·Aug 1, 2018
High RiskFDA
Stryker Gmbh
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Medical Devices·233 affected·Jul 26, 2018
High RiskFDA
Tosoh Bioscience Inc
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in who...
Diabetes Devices·8 affected·Jul 13, 2018
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This...
Respiratory Devices·328 affected·Jul 11, 2018
RecallCPSC
Outdoor Specialty Stores, Ski Shops Nationwide And Direct To Avalanche Professionals, Search And Rescue Personnel And Mountain Guides From July 2010 Through April 2018 For About $350.
ORTOVOX Recalls Avalanche Transceivers Due to Loss of Emergency Communications Capability
Consumer Products·20,000 affected·Jul 10, 2018
High RiskFDA
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Medical Devices·2,131 affected·Jul 3, 2018
High RiskFDA
Hudson Scientific Llc
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the soft...
Medical Devices·35,949 affected·Jul 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·107 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·92 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing ...
Diagnostic Devices·5 affected·Jun 29, 2018
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Comput...
Cardiac Devices·1 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·35 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·115 affected·Jun 29, 2018
High RiskFDA
Luminex Corporation
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner La...
Diagnostic Devices·153 affected·Jun 29, 2018