BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 16, 2023

    Recall

    Recall Number
    Z-1135-2023
    Event Number
    91518
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 16, 2023
    Posted
    February 13, 2023
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60192-2061

    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.

    Action

    SIEMENS Healthineers distributed a Consumer Safety Advisory Notice to its consignees on 01/16/2023 by mail and email. The notice explained the issue and recommended that the following preventive actions be taken until a local Siemens Healthineers service representative has applied the correction: "Mitigation for Biograph Mobile Installations Ensure that the PET/CT Gantry offset protocol is performed every time the coach has moved. If the PET/CT gantry offset fails due to the results being out of tolerance, please cease clinical operations on the system and contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Information on how to acquire the PET/CT Gantry offset protocol is documented in your user documentation. Mitigation for Biograph Seismic Installations In the event of a seismic event, contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Siemens Healthineers will begin dispatching customer service engineers by the end of February 2023 to inspect and make corrections to the locking mechanism to prevent the occurrence of this issue. The resolution for this issue will be delivered by the following Update Instruction: MI516/22/S. Please ensure that this notice is placed in the Biograph Operator Manual and disseminated to all operators of the scanner." "If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below. America: 1-800-888-7436 Europe, Middle East, and Africa: +49 9131 940 4000 Asia and Australia: +86 (21) 3811 2121"

    Distribution

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

    Quantity

    6 units