BEUDAMED
    FDA Recall Terminated

    GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.

    Recall: Z-1713-2008 · Initiated March 29, 2007

    Recall

    Recall Number
    Z-1713-2008
    Event Number
    49533
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 29, 2007
    Posted
    September 30, 2008
    Terminated
    February 4, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.

    Reason

    The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.

    Action

    GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.

    Distribution

    Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.

    Quantity

    132