BEUDAMED
    FDA Recall Terminated

    Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

    Recall: Z-1441-2015 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-1441-2015
    Event Number
    70749
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPY
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 9, 2015
    Posted
    April 13, 2015
    Terminated
    December 21, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

    Reason

    GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.

    Action

    GE Healthcare sent an Urgent Medical Device Correction letter dated March 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA contact 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative.

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.

    Quantity

    797 (3 US, 794 OUS).