BEUDAMED
    FDA Recall Terminated

    GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and 101.25-degree orientations. The other modular core components include a 3-axis universal imaging table, a GENIE Acquisition station, dual Digital CSE (Correlated Signal Enhancement) detectors and high-performance collimators. Features optional real-time body-contoured SPECT and whole body scans, as well as ACuscan, an optional transmission attenuation correction system for SPeC and Gated SPECT scans.

    Recall: Z-0414-06 · Initiated April 18, 2005

    Recall

    Recall Number
    Z-0414-06
    Event Number
    33062
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2005
    Posted
    January 24, 2006
    Terminated
    February 24, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and 101.25-degree orientations. The other modular core components include a 3-axis universal imaging table, a GENIE Acquisition station, dual Digital CSE (Correlated Signal Enhancement) detectors and high-performance collimators. Features optional real-time body-contoured SPECT and whole body scans, as well as ACuscan, an optional transmission attenuation correction system for SPeC and Gated SPECT scans.

    Reason

    In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.

    Action

    Customer letter is being sent to all customers who have an affected system. The letter alerts customers of the potential release of the locking mechanism and requires a Weekly Collimator Exchange Procedure to avoid release of the locking latch until the permanent solution is made available.

    Distribution

    nationwide including Puerto Rico, and to countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Egypt, France, Germany, Iceland, India, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Martinique, Mexico, New Zealand, Philippines Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan and United Kingdom.