BEUDAMED
    FDA Recall Open, Classified

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    Recall: Z-1395-2025 · Initiated February 12, 2025

    Recall

    Recall Number
    Z-1395-2025
    Event Number
    96278
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    LRG
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 12, 2025
    Posted
    March 19, 2025
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    Reason

    Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

    Action

    On February 12, 2025, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to check the manufacturing label on the back or bottom of their printer to confirm if it was one of the affected printers. If the label lists Zebra Technologies as the manufacturer, please use the validation form on the Zebra website to fully validate if your power supply is affected. More information can be found on the Zebra website: https://www.zebra.com/us/en/power-supply-recall.html

    Distribution

    Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas.

    Quantity

    41