BEUDAMED
    FDA Recall Terminated

    Discovery NM 630 Model # H3101RH

    Recall: Z-2994-2020 · Initiated August 14, 2020

    Recall

    Recall Number
    Z-2994-2020
    Event Number
    86337
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    August 14, 2020
    Terminated
    May 6, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Discovery NM 630 Model # H3101RH

    Reason

    Rotor bearing screws were found loose on detector.

    Action

    GE Healthcare issued an Urgent Medical device correction notification on August 14, 2020. It states the following: 1. GE Healthcare will inspect and, if required, correct all affected products at no cost to you. 2. A GE Healthcare representative will contact you to arrange for the correction 3. Please complete the acknowledgement form and return it to GE Healthcare promptly upon receipt and no later than 30 days from receipt to [email protected] If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

    Quantity

    62 units