BEUDAMED
    FDA Recall Terminated

    Advantx 1 SC Model 36006617 Angiographic X-ray System

    Recall: Z-0900-04 · Initiated March 24, 2004

    Recall

    Recall Number
    Z-0900-04
    Event Number
    28747
    Firm
    General Electric Med Systems
    FEI Number
    2126677
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2004
    Posted
    July 20, 2004
    Terminated
    July 24, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Advantx 1 SC Model 36006617 Angiographic X-ray System

    Reason

    Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.

    Action

    Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.

    Distribution

    The units were distributed nationwide in the United States and worldwide.