BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

    Recall: Z-0985-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0985-2015
    Event ID
    70074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 15, 2015
    Termination Date
    April 29, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

    Reason

    Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

    Code Info

    Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

    Distribution

    US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

    Quantity

    13 (7 US, 6 OUS)