BEUDAMED
    FDA Recall Terminated

    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

    Recall: Z-0683-2016 · Initiated December 10, 2015

    Recall

    Recall Number
    Z-0683-2016
    Event Number
    73036
    Firm
    Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany
    FEI Number
    3006653576
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 10, 2015
    Posted
    January 21, 2016
    Terminated
    August 8, 2018

    Description

    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

    Reason

    When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.

    Action

    The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email on 12/10/2015 then followed by 12/17/2015 sent by Fed Ex. The firm requested the mains power be disconnected after setting up the table and BP. Replacement part and instructions will follow.

    Distribution

    Nationwide and International: Algeria, Angola, Arab Republic of Egypt, Austria, Belarus, Belgium, Bulgaria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Ethiopia, France, Germany, Ghana, Greece, Hungary, Iraq, Ireland, Islamic Republic Iran, Italy, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Morocco