BEUDAMED
    FDA Enforcement Class II Terminated

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    Recall: Z-2626-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2626-2017
    Event ID
    77424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EOS Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    May 30, 2017
    Classification Date
    June 23, 2017
    Termination Date
    October 9, 2018
    Address
    4 Ieme Etage, 10 rue Mercoeur, Paris, N/A, N/A, France

    Description

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    Reason

    ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.

    Code Info

    ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,

    Distribution

    US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.

    Quantity

    8 units each