BEUDAMED
    FDA Enforcement Class II Terminated

    Optima CT 540

    Recall: Z-2586-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2586-2018
    Event ID
    80484
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    May 24, 2018
    Classification Date
    July 31, 2018
    Termination Date
    February 8, 2019
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Optima CT 540

    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).

    Code Info

    Serial number 500925HM3, System ID Number 615320OPT

    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