BEUDAMED
    FDA Enforcement Class II Terminated

    Discovery RT labeled as: a. MID BJG; b. HVY BJG

    Recall: Z-2581-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2581-2018
    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 RT labeled as: a. MID BJG; b. HVY BJG

    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

    Model Number 2374682-17. a. MID BJG. Serial Number CBCIG1800017HM (System ID 847695CTRT, UDI 01008406821186991118020021CBCIG1800017HM), Serial Number CBCIG1700070HM (System ID 251665MCIRT, UDI 01008406821186991117120021CBCIG1700070HM), Serial Number CBCIG1700064HM (System ID 973831RT, UDI 01008406821186991117120021CBCIG1700064HM), Serial Number CBCIG1800001HM (System ID 708747RT590, UDI 01008406821186991118010021CBCIG1800001HM); b. HVY BJG. Serial Number CBCIG1700062HM (System ID 904819RTCT, UDI 01008406821186991117120021CBCIG1700062HM), Serial Number CBCIG1700040HM (System ID 843692GSOCT, UDI 01008406821186991117100021CBCIG1700040HM)

    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