BEUDAMED
    FDA Enforcement Class II Ongoing

    Ziehm Vision RFD. Interventional fluoroscopic x-ray system

    Recall: Z-0578-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0578-2025
    Event ID
    95709
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Orthoscan, Inc.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 11, 2024
    Initiation Date
    August 8, 2024
    Classification Date
    December 2, 2024
    Address
    14555 N 82nd St, Scottsdale, AZ, 85260-2525, United States

    Description

    Ziehm Vision RFD. 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.

    Code Info

    UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739.

    Distribution

    U.S. (including Puerto Rico).

    Quantity

    30