BEUDAMED
    FDA Enforcement Class II Ongoing

    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

    Recall: Z-1136-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1136-2023
    Event ID
    91518
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    January 16, 2023
    Classification Date
    February 13, 2023
    Address
    2501 Barrington Rd, N/A, Hoffman Estates, IL, 60192-2061, United States

    Description

    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

    Reason

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    Code Info

    a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068

    Distribution

    Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

    Quantity

    4 units