BEUDAMED
    FDA Recall Terminated

    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    Recall: Z-1999-2016 · Initiated April 25, 2016

    Recall

    Recall Number
    Z-1999-2016
    Event Number
    74239
    Firm
    Siemens Medical Solutions USA Inc.
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 25, 2016
    Posted
    June 15, 2016
    Terminated
    February 1, 2017
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    Reason

    The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

    Action

    Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of China and Malaysia.

    Quantity

    1 unit