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.

51–75 of 118

  • SevereFDA (Devices)·Z-2065-2019·2019-08-21

    Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software

    Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.

    Product
    Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2019·2019-08-14

    Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2019·2019-08-14

    Ortho VITROS 350 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 350 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2179-2019·2019-08-14

    Ortho Clinical Diagnostics Recalls VITROS 5600 Integrated System Analyzers

    Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2175-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.

    Product
    VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0274-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0277-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic Navigation is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D a
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0273-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0278-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0276-2019·2018-10-31

    Medtronic O-arm 1000 2nd Edition Imaging System Software Recall

    Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0280-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits f
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0279-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0005-2019·2018-10-10

    Varian VitalBeam Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling VitalBeam Radiotherapy Delivery Systems due to a software anomaly that may result in treatment without intended respiratory gating.

    Product
    VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2019·2018-10-10

    Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur without intended respiratory gating.

    Product
    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the
    Category
    Medical Device
    Distribution
    Distributed nationwide