The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
487
Critical
2
Severe
30
Most recent
2026-10-14

Of the 487 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (6%) 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 error 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.

226–250 of 487

  • ModerateFDA (Devices)·Z-0693-2019·2019-01-16

    GE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version

    GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.

    Product
    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0552-2019·2019-01-09

    Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error

    Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.

    Product
    StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.…
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0404-2019·2018-11-14

    Medtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall

    Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.

    Product
    Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V800000·2018-11-13

    Volvo Recalls 2017-2019 Models Due to Telematics Software Error

    Volvo is recalling 2017-2019 models because a software error may prevent GPS location data from reaching emergency personnel during a crash.

    Product
    VOLVO — VOLVO XC90, V60, S90, XC60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2019·2018-11-07

    Philips Recalls Vereos PET/CT Software Due to Image Errors

    Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.

    Product
    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V773000·2018-11-01

    Subaru Recalls 2018 Legacy and Outback for Fuel Display Software Error

    Subaru is recalling 2018 Legacy and Outback vehicles because a software error may cause the fuel gauge to display incorrect levels, increasing the risk of stalling and a crash.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2019·2018-10-24

    GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled

    GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.

    Product
    GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2019·2018-10-24

    Baxter Spectrum IQ Infusion System Recalled for Programming Error

    Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.

    Product
    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0101-2019·2018-10-17

    Agfa Healthcare Recalls Enterprise Imaging Desktops Due to Sorting Error

    Agfa Healthcare is recalling 17 Enterprise Imaging Desktops because adding a comparison study may disrupt the chronological sorting of images in the Clinical Side Bar.

    Product
    Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0065-2019·2018-10-10

    Vision RT AlignRT Plus Integrated Gate Controller PCB Recall

    Vision RT Ltd is recalling 690 AlignRT Plus systems due to an RTInterface error that can occur during I/O communication between the Integrated Gate Controller PCB and the Framegrabber PCB.

    Product
    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3188-2018·2018-09-26

    EOS Imaging Recalls sterEOS Workstation Due to 3D Projection Errors

    EOS Imaging is recalling 17 sterEOS workstations because 3D projections may be incorrect when using specific secondary image captures, potentially leading to clinical errors.

    Product
    sterEOS workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2335-2018·2018-07-11

    St Jude Medical Recalls Merlin PCS Programmer Software for ICM Battery Display Error

    St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.

    Product
    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18185·2018-07-10

    Ortovox Recalls Avalanche Transceivers Due to Software Error

    Ortovox is recalling about 20,000 avalanche transceivers because a software error may prevent them from transmitting survivor location data, delaying rescue efforts.

    Product
    Avalanche transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2018·2018-06-27

    Cyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation

    Cyberonics is recalling 252 VNS Therapy Programmer Model 3000 units because certain programming events can miscalculate parameters for implanted generators, potentially causing painful stimulation or lack of therapy.

    Product
    VNS Therapy Programmer, Model 3000, v1.0 System
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2045-2018·2018-06-06

    NordicNeuroLab Recalls nordicBrainEX Software Due to Fiber Tract Alignment Error

    NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2 because a software error can cause fiber tracts to be misaligned when switching between image series with identical resolutions.

    Product
    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2018·2018-05-09

    Siemens SOMATOM Emotion 6 CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Emotion 6 CT scanners because the CARE Dose4D algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.

    Product
    SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1459-2018·2018-05-09

    Siemens SOMATOM Emotion Duo CT Scanner Recalled for Radiation Dose Errors

    Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1454-2018·2018-05-09

    Siemens SOMATOM Sensation 16 CT Scanner Recalled for Dose Calculation Errors

    Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

    Product
    SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1455-2018·2018-05-09

    Siemens SOMATOM Sensation Cardiac CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1597-2018·2018-05-09

    Siemens Biograph Horizon PET/CT Scanner Software Recall for Image Errors

    Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.

    Product
    Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2018·2018-04-11

    Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues

    Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.

    Product
    Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2018·2018-03-14

    Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors

    Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.

    Product
    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems 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
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2018·2018-03-14

    Philips Brilliance Big Bore CT Software Recall for Image Generation Errors

    Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.

    Product
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems 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
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2018·2018-03-14

    Philips IQon Spectral CT Software Recall for Image Misrepresentation

    Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.

    Product
    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    0 states