BEUDAMED
    FDA Recall Terminated

    Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.

    Recall: Z-0220-05 · Initiated December 30, 2004

    Recall

    Recall Number
    Z-0220-05
    Event Number
    30761
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 30, 2004
    Posted
    February 14, 2006
    Terminated
    February 21, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.

    Reason

    Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

    Action

    An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.

    Distribution

    globally

    Quantity

    921