BEUDAMED
    FDA Recall Terminated

    Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD

    Recall: Z-0601-2010 · Initiated February 1, 2009

    Recall

    Recall Number
    Z-0601-2010
    Event Number
    53692
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    KGI
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 1, 2009
    Posted
    January 27, 2010
    Terminated
    December 31, 2011
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD

    Reason

    Failure to properly pre-indicate the technique factors to be used during a patient scan.

    Action

    An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.

    Distribution

    Nationwide Distribution

    Quantity

    1,764 total