The Recall Desk

Hazard

Software Malfunction recalls

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

What the numbers show

Total
140
Critical
0
Severe
12
Most recent
2026-06-17

Of the 140 software malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (9%) 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 malfunction 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.

101–125 of 140

  • HighFDA (Devices)·Z-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2021·2021-09-15

    Solero Generator PG requires software service for startup error

    Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.

    Product
    Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2021·2021-09-08

    CoolSculpting Elite System Software Error May Misreport Thermal Events

    The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

    Product
    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2110-2021·2021-08-18

    Spectrum IQ Infusion System Recalled for Connectivity Errors

    Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.

    Product
    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2111-2021·2021-07-28

    Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates

    Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.

    Product
    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2075-2021·2021-07-21

    Medical device software c4D fails to change site upon synchronization

    C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.

    Product
    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2021·2021-07-14

    ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

    A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

    Product
    ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2021·2021-07-14

    Randox RX Imola Analyzer Software Freeze Recall - 50 Units Affected

    Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.

    Product
    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1900-2021·2021-07-07

    CT Systems Recall: Improperly Loaded Software May Increase X-Ray Radiation

    GE Healthcare is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software that may result in additional X-ray radiation exposure to patients.

    Product
    Revolution EVO, Optima CT660, Optima CT680 CT Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1691-2021·2021-06-09

    Draeger Evita V800 Ventilator Recalled for Multiple Software Defects

    Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2021·2021-06-09

    Critical care ventilators recalled for software defects affecting alarm and operation

    Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2547-2020·2020-07-22

    DiaSorin Simplexa HSV 1&2 Direct Recalled Due to Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa HSV 1&2 Direct test kits because a software malfunction may cause false negative results.

    Product
    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2020·2020-07-22

    DiaSorin Simplexa VZV Swab Direct Recalled for Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa VZV Swab Direct kits due to a software malfunction that may cause false negative results.

    Product
    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2020·2020-03-11

    Tosoh AIA-360 Analyzer Recalled Due to Display Screen Software Freeze

    Tosoh Bioscience Inc is recalling 12 AIA-360 Automated Immunoassay Analyzers because a software issue causes the display to freeze and stop the instrument.

    Product
    AIA-360 Automated Immunoassay Analyzer, Product Code 019945
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0171-2020·2019-10-30

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 47,152 Plum 360 Infusion Systems because a software malfunction can cause the device to become inoperable with a blank screen when used with a MedNet Custom Drug Library.

    Product
    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2764-2019·2019-10-09

    ELITech Viva-ProE Systems Recalled for Software Malfunction

    ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.

    Product
    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2019·2019-07-17

    Canon Radrex-i X-Ray System Software Malfunction Recall

    Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

    Product
    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2019·2018-11-07

    Fresenius Kabi Recalls Volumat MC Agilia Infusion Pumps for Software Upgrade

    Fresenius Kabi is recalling 7,082 Volumat MC Agilia Volumetric Infusion Pumps to install a mandatory software upgrade that prevents common software malfunctions.

    Product
    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2019·2018-10-31

    Data Innovations Recalls Abbott Alinity ci-series Software Driver

    Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.

    Product
    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2184-2018·2018-06-20

    CellaVision DM Software Recall for LIS Data Transmission Malfunction

    Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.

    Product
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2018·2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2018·2018-02-07

    Roche Elecsys 2010 Analyzer Software Malfunction Recall

    Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.

    Product
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
    Category
    Medical Device
    Distribution
    Distributed nationwide
Software Malfunction recalls · The Recall Desk