The Recall Desk

Hazard

Software Anomaly recalls

118 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
118
Critical
4
Severe
10
Most recent
2026-07-15

Of the 118 software anomaly recalls we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software anomaly recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–118 of 118

  • HighFDA (Devices)·Z-0864-2015·2014-12-31

    Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly

    Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and c
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0821-2015·2014-12-24

    Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error

    Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0078-2015·2014-10-22

    Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.

    Product
    VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2015·2014-10-22

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause unexpected assay calibration when using specific calibrator barcode labels.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Sli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1738-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.

    Product
    enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modifica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.

    Product
    enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in th
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1677-2014·2014-06-11

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

    Product
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2014·2014-06-11

    Spacelabs Ultraview SL Command Module Recalled for Software Anomaly

    Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.

    Product
    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0941-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2013·2013-08-14

    Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error

    Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.

    Product
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and cond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2013·2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0674-2013·2013-01-23

    Philips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies

    Philips Medical Systems is recalling nine CT scanning systems due to software anomalies that could pose a risk of injury to patients and personnel if the issues recur.

    Product
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to pr
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2259-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations fo
    Category
    Medical Device
    Distribution
    Distributed nationwide