BEUDAMED
    FDA Enforcement Class II Terminated

    MAC VU360, Electrocardiograph

    Recall: Z-0543-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0543-2021
    Event ID
    86725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    October 27, 2020
    Classification Date
    December 7, 2020
    Termination Date
    May 3, 2024
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    MAC VU360, Electrocardiograph

    Reason

    Incorrect patient identification and/or patient demographic errors.

    Code Info

    Model: 2030360 001

    Distribution

    Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom.

    Quantity

    5,284 units