BEUDAMED
    FDA Recall Terminated

    Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects

    Recall: Z-0494-2010 · Initiated August 1, 2009

    Recall

    Recall Number
    Z-0494-2010
    Event Number
    53883
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 1, 2009
    Posted
    January 21, 2010
    Terminated
    February 4, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects

    Reason

    Failure to provide the complete User Manual information.

    Action

    A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.

    Distribution

    Nationwide Distribution

    Quantity

    343 total