BEUDAMED
    FDA Recall Terminated

    GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting 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-1304-06 · Initiated May 15, 2006

    Recall

    Recall Number
    Z-1304-06
    Event Number
    36173
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2006
    Posted
    September 22, 2006
    Terminated
    May 25, 2007
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting 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

    Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam

    Action

    An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.

    Distribution

    Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.

    Quantity

    1,289