The Recall Desk

Hazard

Software Defect recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software defect 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.

176–200 of 316

  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V007000·2024-04-01

    Peterbilt 579 and Kenworth T680 electronic stability control software defect

    PACCAR is recalling approximately 46 Peterbilt 579 (2022-2023) and Kenworth T680 (2023) vehicles with faulty electronic stability control software that may underestimate vehicle mass, reducing crash prevention performance. Dealers will provide a free software update.

    Product
    PETERBILT — 2022 PETERBILT 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2024·2024-03-13

    Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2024·2024-03-13

    VITROS Diagnostic System Software Defect May Cause Erroneous Patient Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2024·2024-03-13

    Laboratory analyzer software defect may cause erroneous patient test results

    A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2024·2024-03-13

    Synapse PACS version 7.3.000 produces incorrect breast imaging measurements

    FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.

    Product
    Synapse PACS - Version 7.3.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging

    Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2024·2024-03-13

    VITROS 4600 Chemistry System Software Defect Affects Quality Control Reporting

    A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2024·2024-03-13

    Laboratory chemistry system software defect impairs quality control reporting

    A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2024·2024-03-13

    Medical Device Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2024·2024-03-13

    Medical device software defect may cause incorrect laboratory test results

    A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V747000·2024-03-10

    2025 INFINITI QX80 Rear Camera May Freeze in Reverse

    A software error may cause the rearview camera in 2025 INFINITI QX80 vehicles to freeze and display a blank screen when in reverse, reducing rear visibility and increasing crash risk. Dealers will reprogram the AVM software free of charge.

    Product
    INFINITI — 2025 INFINITI QX80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2024·2024-02-07

    Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement

    Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2024·2024-01-17

    Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis

    Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.

    Product
    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V827000·2024-01-11

    2025 Rivian R1S and R1T exterior lights may fail due to software

    Software in 2025 Rivian R1S and R1T vehicles may disable exterior lights when the Car Costume feature is activated, reducing visibility and increasing crash risk. Rivian released a free software update to fix the issue.

    Product
    RIVIAN — 2025 RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2024·2024-01-10

    Covidien Valleylab FT10 Energy Platform software issue causes inoperability

    Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.

    Product
    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V265000·2024-01-04

    2021 RAM 1500 Recalled for Engine Stall Risk from Software Defect

    Chrysler is recalling 2021 RAM 1500 trucks (5.7L eTorque) for an engine stall issue caused by powertrain control software. Engine stall can increase crash risk; dealers will update the software free of charge.

    Product
    RAM — 2021 RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states