BEUDAMED
    FDA Recall Terminated

    GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

    Recall: Z-1257-2009 · Initiated March 12, 2009

    Recall

    Recall Number
    Z-1257-2009
    Event Number
    51879
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 12, 2009
    Posted
    September 25, 2009
    Terminated
    December 10, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

    Reason

    Failure to provide the certification label required by 21 CFR 1010.2.

    Action

    A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.

    Distribution

    Nationwide Distribution

    Quantity

    1179 total of all units