BEUDAMED
    FDA Enforcement Class II 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 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1999-2016
    Event ID
    74239
    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 22, 2016
    Initiation Date
    April 25, 2016
    Classification Date
    June 15, 2016
    Termination Date
    February 1, 2017
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562, United States

    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.

    Code Info

    Serial Number 11009

    Distribution

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

    Quantity

    1 unit