BEUDAMED
    FDA Recall Terminated

    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint 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-2035-2016 · Initiated April 22, 2016

    Recall

    Recall Number
    Z-2035-2016
    Event Number
    74192
    Firm
    Siemens Medical Solutions USA Inc.
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2016
    Posted
    June 21, 2016
    Terminated
    May 8, 2017
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint 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

    Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Action

    Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    4 units