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.

851–875 of 1375

  • ModerateFDA (Devices)·Z-0768-2017·2016-12-21

    Beckman Coulter Recalls MicroScan LabPro Data Management System Software

    Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

    Product
    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0707-2017·2016-12-14

    Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors

    Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.

    Product
    Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2017·2016-12-14

    Philips Spectral CT Software Recalled for Image Processing Defects

    Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.

    Product
    Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0705-2017·2016-12-14

    Philips IQon Spectral CT Software Defect Recall

    Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.

    Product
    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0668-2017·2016-12-07

    Elekta Monaco TRP System Software Recall for CT Data Handling Error

    Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.

    Product
    Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0599-2017·2016-11-23

    Merge PACS software recall due to unviewed image display defect

    Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy System Software Defect Recall

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to a software defect that causes 2D contour projections to appear off from their true position.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.

    Product
    SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2017·2016-11-23

    Siemens Recalls SOMATOM Definition AS CT Systems for Software Update

    Siemens is recalling seven SOMATOM Definition AS CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2017·2016-11-23

    Merge Healthcare Recalls iConnect Access Software Due to Display Error

    Merge Healthcare is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2 because the software displayed incorrect prior reports when viewing multiple studies.

    Product
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V839000·2016-11-18

    Maserati Recalls 2017 Models for Backup Camera Software Defect

    Maserati is recalling 7,481 model year 2017 Quattroporte, Ghibli, and Levante vehicles because the backup camera may disable in freezing temperatures, increasing crash risk.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI, LEVANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2017·2016-11-02

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Software Anomaly

    Intuitive Surgical is recalling 677 da Vinci Xi Surgical Systems due to a software anomaly that may cause unexpected movement.

    Product
    da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0137-2017·2016-10-26

    Merge Healthcare CADstream software recall for missing PURE filter message

    Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.

    Product
    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2017·2016-10-26

    Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up

    Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.

    Product
    CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2016·2016-10-05

    Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.

    Product
    PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2016·2016-10-05

    Siemens Syngo RT Therapist Software Recalled for Safety Issues

    Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.

    Product
    Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2876-2016·2016-10-05

    Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.

    Product
    ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2892-2016·2016-10-05

    Siemens Medical Solutions Recalls Syngo.plaza VB10A Picture Archiving Systems

    Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.

    Product
    Syngo.plaza VB10A, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2016·2016-10-05

    Siemens Syngo.plaza PACS Software Recall for Multiple Issues

    Siemens Medical Solutions is recalling 47 Syngo.plaza Picture Archiving and Communication System units to address several software issues.

    Product
    Syngo.plaza, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V708000·2016-10-04

    REV Recalls 2010-2016 Road Rescue Vehicles Due to Touchscreen Software Defect

    REV is recalling 2010-2016 Road Rescue and other emergency vehicles because touchscreen software may cause accessories to turn on or off unexpectedly, increasing crash risk.

    Product
    ROAD RESCUE — ROAD RESCUE SPECIALTY VEHICLE, ULTRAMEDIC, TRANSMEDIC, DURAMEDIC
    Category
    Vehicle
    Distribution
    Distributed nationwide