The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 106 (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 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.

451–475 of 1375

  • SevereNHTSA·21V120000·2021-02-25

    Thomas Built Buses Recalls Saf-T-Liner C2 School Buses for Engine Software Defect

    Daimler Trucks North America is recalling 2019-2021 Thomas Built Buses Saf-T-Liner C2 school buses because engine software may fail to limit speed or torque, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2020·2021-02-03

    Philips Telemetry Transceiver Recall for Heart Rate Display Failure

    Philips is recalling TRx4841A telemetry transceivers because they may fail to display heart rates or alarms when used with specific Patient Information Center software.

    Product
    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0918-2021·2021-02-03

    Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors

    Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.

    Product
    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0727-2021·2021-02-03

    Philips ProxiDiagnost N90 X-ray System Recalled for Software Lock-in Defect

    Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.

    Product
    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2021·2021-01-27

    Roche uPath software 1.1 recalled for incorrect measurement calculations

    Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.

    Product
    uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0861-2021·2021-01-20

    Siemens Atellica CH 930 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2021·2021-01-20

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue

    ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.

    Product
    icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2021·2021-01-20

    Siemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2021·2021-01-20

    Siemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.23.2 or lower because the software may report discrepant patient results.

    Product
    Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0771-2021·2021-01-20

    Siemens SOMATOM CT Scanner Software Recall for Scan Parameter Issues

    Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.

    Product
    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2021·2021-01-20

    Medtronic Intellis Spinal Cord Stimulator Software Recall

    Medtronic is recalling the Intellis Spinal Cord Stimulator software due to a defect that prevents clinicians from programming the implantable neurostimulation device.

    Product
    Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2021·2020-12-30

    B Braun APEX Compounding System Control Panel Module Recalled

    B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.

    Product
    APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2021·2020-12-30

    GE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors

    GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2021·2020-12-23

    RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

    RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

    Product
    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V810000·2020-12-23

    International DuraStar and WorkStar Engine Control Software Defect Recall

    Navistar recalls 17,213 2014-2021 International commercial trucks with an engine control defect. The software flaw can cause unexpected vehicle movement when parked with the PTO engaged, risking crashes and injury.

    Product
    INTERNATIONAL — INTERNATIONAL MV, DURASTAR, WORKSTAR, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2021·2020-12-16

    Shimadzu MH-200S X-Ray System Recalled for Ceiling Arm Software Defect

    Shimadzu Medical Systems is recalling 22 MH-200S X-Ray systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2021·2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2021·2020-12-16

    Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

    Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

    Product
    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2021·2020-12-16

    Canon CT Scanner Recall for Software Issue Causing Scan Failures

    Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.

    Product
    Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2021·2020-12-02

    RayStation software recall for potential incorrect treatment plan references

    RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.

    Product
    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2021·2020-11-25

    Roche Recalls cobas infinity Software Due to Incorrect Validation

    Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.

    Product
    cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2021·2020-11-25

    Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

    Product
    Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2021·2020-11-18

    Inpeco FlexLab Automation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
    Category
    Medical Device
    Distribution
    0 states