BEUDAMED
    FDA Enforcement Class II Terminated

    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 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-2032-2016 · Reported June 29, 2016

    Enforcement

    Recall Number
    Z-2032-2016
    Event ID
    74192
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    June 21, 2016
    Termination Date
    May 8, 2017
    Address
    810 Innovation Dr, N/A, Knoxville, TN, 37932-2562, United States

    Description

    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 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.

    Code Info

    Serial Numbers: 1003,1004,1005,1006,1007,11009,11010,11011,11012,11013,11014,11023,11015,11016,11017,11018,11019,11020,11021,11022,11025,11028,11029,11027,31042,11024,11026,11033,11032,21034,31037,31040,21035,11031,11030,21036,31038,31039,31046,31041,31043,31045,31047,31048,31044,31049, 31050,31051,31054,1008,31053

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    51 units