BEUDAMED
    FDA Recall Open, Classified

    Ziehm Solo FD. Interventional fluoroscopic x-ray system

    Recall: Z-0574-2025 · Initiated August 8, 2024

    Recall

    Recall Number
    Z-0574-2025
    Event Number
    95709
    Firm
    Orthoscan, Inc.
    FEI Number
    3005254598
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 8, 2024
    Posted
    December 2, 2024
    Address
    14555 N 82nd St, Scottsdale, AZ, 85260-2525

    Description

    Ziehm Solo FD. Interventional fluoroscopic x-ray system

    Reason

    Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

    Action

    Ziehm Imaging, Inc. intends to notify the affected customers directly in the following manner: 1) Letter with return receipt requested, envelope, return, and reply to questionnaire, or E-mail contact. 2) Direct phone calls. Once contact is made and confirmed Ziehm Imaging Inc, shall provide replacement hand switch and instructions to the end user. Wired Hand switch 88036 Vl.02 will be requested to be returned by the customer/end user to Ziehm Imaging Inc. and will be subjected to be scrapped.

    Distribution

    U.S. (including Puerto Rico).

    Quantity

    25