BEUDAMED
    FDA Enforcement Class II Terminated

    Discovery MI Digital Ready

    Recall: Z-2579-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2579-2018
    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

    Discovery MI Digital Ready

    Reason

    DIGITAL ReadyCT/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

    Model Number 5986030. a. Serial Number PTDMI1800003PT, System ID Number RADNETPT1839, UDI Number 01008406821209751118010421PTDMI1800003PT; b. Serial Number PTDMI1800005PT, System ID Number RADNETPT1838, UDI Number 01008406821209751118010421PTDMI1800003PT; c. Serial Number PTDMI1800009PT, System ID Number 813745DMIDR2, UDI Number 01008406821209751118021921PTDMI1800009PT

    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