The Recall Desk

Hazard

Software Malfunction recalls

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

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.

101–109 of 109

  • 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
    0 states
  • 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-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
  • 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
  • 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-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-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