BEUDAMED
    FDA Recall Terminated

    SMV FX-80 Nuclear Camera

    Recall: Z-1394-04 · Initiated July 30, 2004

    Recall

    Recall Number
    Z-1394-04
    Event Number
    29756
    Firm
    General Electric Med Systems
    FEI Number
    2126677
    Product Code
    IYX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2004
    Posted
    August 24, 2004
    Terminated
    July 24, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    SMV FX-80 Nuclear Camera

    Reason

    The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.

    Action

    The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out.

    Distribution

    Inside the US. Manufactured and distributed from 1993 - 2000.

    Quantity

    41