BEUDAMED
    FDA Recall Open, Classified

    Mobilett Mira wireless (VA20) mobile x-ray system(s)

    Recall: Z-0223-2024 · Initiated October 5, 2023

    Recall

    Recall Number
    Z-0223-2024
    Event Number
    93304
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 5, 2023
    Posted
    November 14, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Mobilett Mira wireless (VA20) mobile x-ray system(s)

    Reason

    Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.

    Action

    Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.

    Distribution

    US Nationwide - Worldwide

    Quantity

    4 distributed in U.S.