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.

601–625 of 1335

  • ModerateFDA (Devices)·Z-0823-2019·2019-02-20

    Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues

    Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.

    Product
    Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2019·2019-02-13

    NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error

    Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY tran
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0782-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

    Product
    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2019·2019-02-06

    Siemens Recalls Atellica Sample Handler Prime Due to Software Issues

    Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.

    Product
    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2019·2019-01-30

    Varian Eclipse Treatment Planning System Proton Algorithm Recall

    Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.

    Product
    Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V031000·2019-01-14

    Ford Recalls 2019 Lincoln Nautilus for Lane Center Assist Defect

    Ford is recalling 2019 Lincoln Nautilus vehicles because the Lane Center Assist system may fail to detect if the driver's hands are off the steering wheel for a prolonged period.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V935000·2018-12-31

    Subaru Recalls 2018 Models for Rearview Camera Software Defect

    Subaru is recalling 2018 Legacy, Outback, and BRZ vehicles because a software issue may prevent the rearview camera from displaying an image while backing up.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, BRZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0497-2019·2018-12-26

    COVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues

    COVIDIEN LLC is recalling 9,593 Puritan Bennett 980 ventilators worldwide due to a software update affecting external USB drive performance and GUI functionality.

    Product
    Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient popu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2019·2018-12-26

    Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors

    Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.

    Product
    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2019·2018-12-26

    GE Healthcare Recalls Centricity Universal Viewer Software Due to Orientation Marker Errors

    GE Healthcare is recalling specific versions of the Centricity Universal Viewer Zero Footprint Client because orientation markers may display incorrectly after image manipulation.

    Product
    Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0470-2019·2018-12-05

    Synaptive Medical Recalls BrightMatter Guide Software Due to Defect

    Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.

    Product
    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2019·2018-12-05

    GE Healthcare Recalls Solar 8000M Patient Monitoring Systems

    GE Healthcare is recalling Solar 8000M patient monitors because they may restart simultaneously during network overload, potentially disrupting patient monitoring.

    Product
    Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2019·2018-12-05

    PerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall

    PerkinElmer is recalling 18 QSight 210 MD mass spectrometers because a software defect may overwrite original data from the last acquired sample when automatic flush is enabled.

    Product
    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0519-2019·2018-12-05

    GE Healthcare Recalls Dash 3000 Patient Monitoring Systems

    GE Healthcare is recalling Dash 3000 patient monitors because they may restart simultaneously during prolonged network overloads.

    Product
    Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2019·2018-11-28

    Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug

    Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.

    Product
    Insulia Diabetes Management Companion
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0485-2019·2018-11-28

    Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing

    Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.

    Product
    Tosoh AIA-900 immunoassay Analyzer
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·18V833000·2018-11-27

    Lamborghini Recalls Gallardo Vehicles Due to Software Warning Failure

    Lamborghini is recalling 2011-2014 Gallardo vehicles because engine software may erase trouble codes, preventing warning lamps from illuminating for safety system failures.

    Product
    LAMBORGHINI — LAMBORGHINI GALLARDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2019·2018-11-21

    Invivo Xper Flex Cardio Physiomonitoring System Software Recall

    Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.

    Product
    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states