The Recall Desk

Hazard

Software Failure recalls

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

What the numbers show

Total
42
Critical
0
Severe
4
Most recent
2026-08-26

Of the 42 software failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software failure 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.

26–42 of 42

  • HighFDA (Devices)·Z-2746-2017·2017-07-26

    Medtronic Navigation Recalls Spine Tool Install CD Version 25

    Medtronic Navigation is recalling 108 Spine Tool Install CD units (Model 9731958) due to a software issue that may prevent navigation of surgical instruments during spine procedures.

    Product
    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2017·2017-04-05

    Merge Eye Care Systems Software Recall Due to Image Acquisition Failure

    Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.

    Product
    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2017·2017-03-01

    Tosoh G8 Reporting Software Recalled Due to Power Outage Shutdowns

    Tosoh Smd Inc is recalling 34 units of Reporting Software for the G8 analyzer because power outages cause the software to shut down.

    Product
    Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2016·2016-06-29

    Fresenius CLiC Monitor Recall for Potential Hemodialysis Pump Stoppage

    Fresenius Medical Care is recalling 875 CLiC monitors used with 2008T hemodialysis machines because a frozen screen may cause the blood pump to stop.

    Product
    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2016·2016-01-13

    Vidco MDP 2000 Remote Patient Monitoring Systems Recalled for Freezing

    Vidco, Inc. is recalling 59 MDP 2000 Series Remote Patient Monitoring Systems because they may freeze and fail to reset without a power cycle.

    Product
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2016·2015-12-02

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2015·2015-09-09

    Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup

    Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.

    Product
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1621-2015·2015-05-27

    bioMerieux MYLA Server Software Recalled for Processing Failures

    bioMerieux is recalling MYLA V3 server software because it may stop processing data in high-volume settings, requiring remote or on-site service.

    Product
    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2611-2014·2014-09-17

    Illumina Worklist Manager Software Recalled for Performance Failure

    Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.

    Product
    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2014·2014-04-23

    SpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure

    Del Mar Reynolds Medical is recalling 16 SpaceLabs Arkon Anesthesia Delivery Systems with Version 2.0 software because they may enter a controlled failed state.

    Product
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2014·2014-03-12

    GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure

    GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.

    Product
    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2014·2014-02-12

    Philips Diagnostic Imaging Systems Recalled for Database Lockup

    Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.

    Product
    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0491-2014·2014-01-15

    Carestream DRX-Revolution Mobile X-Ray Systems Recalled for Image Retrieval Failure

    Carestream Health Inc. is recalling 310 mobile X-ray systems because processed images could not be found, leading to patient re-exposure.

    Product
    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Thes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2014·2013-11-27

    GE Vivid E9 Ultrasound Systems Recalled for Software Lockup

    GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.

    Product
    GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2013·2013-07-03

    GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues

    GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.

    Product
    CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2013·2013-04-24

    Maquet Cardiohelp Support System Recalled for Unexpected Shutdowns

    Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.

    Product
    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support
    Category
    Medical Device
    Distribution
    Distributed nationwide