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.

576–600 of 1375

  • HighFDA (Devices)·Z-0176-2020·2019-10-30

    Brainlab Patient Data Manager Software Recall for Data Export Errors

    Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.

    Product
    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2020·2019-10-30

    Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2020·2019-10-30

    Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy plans.

    Product
    Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2019·2019-10-02

    Accu-Chek Connect App Recall for Android Data Transfer Failure

    Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2019·2019-09-04

    Agilent MassHunter Software Recall Due to Sample Data Mismatch

    Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.

    Product
    MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2064-2019·2019-08-21

    Fenwal Volumat MC Agilia Infusion Pump Software Recall

    Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.

    Product
    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2019·2019-08-21

    Siemens SOMATOM Drive CT Systems Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling SOMATOM Drive CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2019·2019-08-21

    Siemens SOMATOM CT Systems Recalled for Software Scan Abort Risk

    Siemens is recalling SOMATOM Definition Flash CT systems due to four software issues that may cause scans to abort.

    Product
    SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2019·2019-08-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Issues

    Siemens Medical Solutions USA is recalling SOMATOM Definition AS CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.

    Product
    SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2019·2019-08-21

    Siemens SOMATOM Edge Plus CT Systems Recalled for Software Issues

    Siemens is recalling SOMATOM Edge Plus CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.

    Product
    SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2019·2019-08-21

    Siemens SOMATOM Confidence CT Systems Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling SOMATOM Confidence CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2019·2019-08-21

    Siemens CT Systems Recalled for Software Issues Causing Scan Aborts

    Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in scan aborts.

    Product
    SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2019·2019-08-21

    Siemens SOMATOM Force CT Systems Recalled for Software Scan Abort Issues

    Siemens Medical Solutions is recalling SOMATOM Force CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2019·2019-08-14

    Abbott Alinity ci-series System Control Modules Recalled for Software Defect

    Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.

    Product
    The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2182-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2019·2019-08-14

    Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue

    Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2019·2019-08-07

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.

    Product
    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1997-2019·2019-08-07

    Philips Recalls Azurion X-ray Systems Due to Software Defect

    Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.

    Product
    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2019·2019-07-31

    Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts

    Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.

    Product
    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2062-2019·2019-07-31

    Merge PACS Software Recalled for Mammography Image Display Errors

    Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.

    Product
    Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2063-2019·2019-07-31

    Merge OrthoPACS Software Recalled for Image Display Ordering Issues

    Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.

    Product
    Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical…
    Category
    Medical Device
    Distribution
    2 states