BEUDAMED
    FDA Recall Terminated

    Biograph mCT S(40)-4R, System Material Number 10248671. 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-0811-2015 · Initiated November 13, 2014

    Recall

    Recall Number
    Z-0811-2015
    Event Number
    69897
    Firm
    Siemens Medical Solutions USA Inc.
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 13, 2014
    Posted
    December 16, 2014
    Terminated
    July 9, 2015
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    Biograph mCT S(40)-4R, System Material Number 10248671. 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

    Possibility for system display freeze during CT interventional procedures.

    Action

    The firm initiated their recall by certified mail on 11/13/2014.

    Distribution

    Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.

    Quantity

    8 units total