BEUDAMED
    FDA Recall Terminated

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    Recall: Z-2587-2018 · Initiated May 24, 2018

    Recall

    Recall Number
    Z-2587-2018
    Event Number
    80484
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 24, 2018
    Terminated
    February 8, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    Reason

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

    Action

    GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.

    Distribution

    Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

    Quantity

    42 units total