BEUDAMED
    FDA Enforcement Class II Ongoing

    SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

    Recall: Z-1135-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1135-2023
    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 mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

    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) Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047; b) S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054; c) S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091; d) S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047; e) S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076; f) S(20)-3R Mobile, UDI/DI 405686900129660028, , Material Number 10534159, Serial Number 60028

    Distribution

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

    Quantity

    6 units