The Recall Desk

Hazard

Software Defect recalls

1,335 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,335
Critical
14
Severe
91
Most recent
2026-09-09

Of the 1,335 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 91 (7%) 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.

401–425 of 1335

  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1517-2021·2021-05-05

    Philips Recalls Xper Flex Cardio Monitors Due to Performance Issues

    Philips is recalling Xper Flex Cardio monitors due to software issues that may cause display delays, freezing, or incorrect data.

    Product
    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1497-2021·2021-05-05

    Siemens Recalls ARTIS X-Ray Systems Due to Software Issue

    Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.

    Product
    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1307-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect

    Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.

    Product
    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards desi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1308-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect

    Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.

    Product
    VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent ca
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2021·2021-03-17

    Thermo Fisher Recalls Cascadion Clinical Analyzer Due to Software Defect

    Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.

    Product
    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·21V181000·2021-03-16

    Peterbilt 536 Recalled for Engine Control Module Software Defect

    PACCAR is recalling one 2021 Peterbilt 536 truck because incorrect engine software may prevent safety features like braking and stability control from functioning properly.

    Product
    PETERBILT — PETERBILT 536
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-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 i
    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-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 in
    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 i
    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
  • 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
  • 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, 9.2
    Category
    Medical Device
    Distribution
    Distributed nationwide