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.

626–650 of 1335

  • HighFDA (Devices)·Z-0411-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems for Missing Backup Ventilation Feature

    GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.

    Product
    Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2019·2018-11-14

    GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

    GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0294-2019·2018-11-07

    RayStation Software Recalled for Unsupported Robust Optimization Feature

    RaySearch Laboratories AB is recalling RayStation software versions 4.5 through 7 because robust optimization for specific plans is not supported.

    Product
    RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0229-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0230-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 8 BACT/ALERT VIRTUO systems because firmware version R2.0 allows calibration standards to be moved, potentially causing anomalies if not returned to designated locations.

    Product
    BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2019·2018-10-31

    Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects

    Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.

    Product
    Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0275-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0112-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems worldwide because software issues may cause flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2019·2018-10-24

    Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.

    Product
    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2019·2018-10-24

    Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.

    Product
    Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2019·2018-10-24

    Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

    Product
    Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0194-2019·2018-10-24

    Siemens Atellica Analyzer Software Recall for Diagnostic Errors

    Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.

    Product
    Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2019·2018-10-24

    Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Connect software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

    Product
    Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0096-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.

    Product
    GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facili
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0095-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.

    Product
    GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2019·2018-10-10

    OptiMedica Catalys Precision Laser System Recalled for Software Alignment Failures

    Johnson & Johnson is recalling nine Catalys Precision Laser Systems because a software upgrade causes alignment verification cuts to mismatch the intended treatment overlay.

    Product
    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product La
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3240-2018·2018-10-03

    Stryker Recalls Hoffmann LRF Hexapod Software Due to Calculation Error

    Stryker GmbH is recalling 233 units of Hoffmann LRF Hexapod Software because it may compute erroneously accelerated correction plans under specific settings.

    Product
    Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2018·2018-10-03

    Medtronic Visualase Thermal Therapy System Recalled for MR Thermometry Inaccuracy

    Medtronic is recalling Visualase Thermal Therapy System software due to potential MR thermometry inaccuracies that may cause unaccounted thermal energy spread during laser ablation.

    Product
    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-3194-2018·2018-09-26

    Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

    Product
    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3192-2018·2018-09-26

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error

    Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.

    Product
    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V676000·2018-09-26

    Midwest Fire Recalls All-Poly Series Emergency Vehicles Due to Software Defect

    Midwest Fire is recalling 2014-2019 All-Poly Series emergency vehicles because touchscreen software may cause accessories to turn on or off unexpectedly, increasing crash risk.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide