The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 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 26 (5%) 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.

201–225 of 482

  • ModerateFDA (Devices)·Z-0241-2020·2019-11-06

    Medtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates

    Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0237-2020·2019-11-06

    Mindray Rosie4 Vital Signs Monitor Recalled for Software Clearance Issues

    Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0160-2020·2019-10-30

    Siemens Mammomat Revelation Recall for Biopsy Software Error

    Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.

    Product
    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2019·2019-09-18

    Zeus Scientific Recalls Dynex DSX Software for False Negative ELISA Results

    Zeus Scientific is recalling 28 Dynex DSX software files due to a programming error that causes false negative results in specific ELISA assays.

    Product
    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2019·2019-09-11

    Haag-Streit Operating Microscope Floor Stand Software Error Recall

    Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS H
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2484-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2482-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.

    Product
    HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS H
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2363-2019·2019-09-04

    Abbott Recalls Alinity ci Series System Control Modules Due to Software Error

    Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.

    Product
    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V589000·2019-08-12

    BMW Recalls 2020 745e xDrive for Seat Belt Warning Software Error

    BMW is recalling 2020 745e xDrive vehicles because a software error may disable the audible seat belt warning for the driver, increasing injury risk in a crash.

    Product
    BMW — BMW 745E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2019·2019-07-31

    Getinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages

    Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.

    Product
    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V540000·2019-07-19

    Mercedes-Benz Recalls Vehicles for Radar Sensor Software Error

    Mercedes-Benz is recalling 2019-2020 vehicles because a software error in the radar sensor may impair Active Brake Assist, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS 450, C 300, E 450, E 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2019·2019-07-03

    Hitachi PROBEAT-V Proton Therapy System Software Recall

    Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.

    Product
    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1850-2019·2019-06-26

    Arkray AUTION HYBRID AU-4050 Recalled for Software Error

    Arkray Factory USA, Inc. is recalling 159 AUTION HYBRID AU-4050 units due to a software issue that could assign incorrect patient information to sample results.

    Product
    AUTION HYBRID AU-4050
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1207-2019·2019-05-01

    Carestream OnSight 3D Extremity System Recalled for Software Data Error

    Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.

    Product
    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2019·2019-04-10

    Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

    Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.

    Product
    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1078-2019·2019-04-10

    Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error

    Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.

    Product
    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A6
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0959-2019·2019-03-06

    Shimadzu BRANSIST safire Digital Angiography System Software Recall

    Shimadzu Medical Systems is recalling eight BRANSIST safire digital angiography systems due to a software error that can cause abnormal termination during initial patient registration.

    Product
    BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0936-2019·2019-03-06

    Siemens Sensis Vibe System Recalled for Software Crash Risk

    Siemens Medical Solutions is recalling one Sensis Vibe System unit due to a software error that may cause system crashes during clinical procedures.

    Product
    Sensis Vibe System, Model Number 11007642, with software version VD10B.
    Category
    Medical Device
    Distribution
    1 state
  • 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 cross-
    Category
    Medical Device
    Distribution
    Distributed nationwide