BEUDAMED
    FDA Recall Terminated

    GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.

    Recall: Z-0833-2012 · Initiated January 31, 2011

    Recall

    Recall Number
    Z-0833-2012
    Event Number
    57842
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    RCE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 31, 2011
    Posted
    February 17, 2012
    Terminated
    September 6, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.

    Reason

    Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.

    Action

    GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011.

    Distribution

    Worldwide Distribution

    Quantity

    21