BEUDAMED
    FDA Recall Terminated

    EasyDiagnost Eleva x-ray systems

    Recall: Z-0353-2009 · Initiated December 10, 2008

    Recall

    Recall Number
    Z-0353-2009
    Event Number
    50742
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 10, 2008
    Posted
    September 24, 2009
    Terminated
    August 17, 2012
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    EasyDiagnost Eleva x-ray systems

    Reason

    Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

    Action

    An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C

    Distribution

    Worldwide Distribution

    Quantity

    332 units