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.

676–700 of 1375

  • 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-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-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-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 #…
    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-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-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-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…
    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…
    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…
    Category
    Medical Device
    Distribution
    5 states
  • 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
  • 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
  • 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-3195-2018·2018-09-26

    Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.

    Product
    2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, 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
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    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
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V621000·2018-09-14

    Mitsubishi Recalls Outlander Models Due to Safety System Software Defect

    Mitsubishi is recalling 2017-2018 Outlander, Outlander Sport, Eclipse Cross, and Outlander PHEV vehicles because incorrect software may prevent safety systems like automatic emergency braking from functioning.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER SPORT, ECLIPSE CROSS, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V625000·2018-09-13

    Land Rover Recalls 2018 Models for Silent Automatic Emergency Braking Failure

    Jaguar Land Rover is recalling 2018 Discovery, Range Rover, and Range Rover Sport vehicles because the Automatic Emergency Braking system may disable without warning, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER DISCOVERY, RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V607000·2018-09-11

    Mercedes-Benz Recalls 2018 AMG S63 and S65 for Lane Keeping Software Defect

    Mercedes-Benz is recalling 2018 AMG S63 and S65 vehicles because the Active Lane Keeping Assist software may fail to intervene during unintended lane departures above 65 mph.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, AMG S65
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2018·2018-08-29

    Liebel-Flarsheim Direct Digital Imaging System Recalled for Software Display Discrepancy

    Liebel-Flarsheim is recalling 28 Direct Digital Imaging Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics…
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2833-2018·2018-08-29

    Liebel-Flarsheim Hydra Vision Urology X-Ray System Recalled for Software Issue

    Liebel-Flarsheim is recalling 313 Hydra Vision Urology X-Ray Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics…
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2745-2018·2018-08-22

    Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference

    Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.

    Product
    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol…
    Category
    Medical Device
    Distribution
    Distributed nationwide