BEUDAMED
    FDA Recall Terminated

    LithoDiagnost

    Recall: Z-1661-2009 · Initiated July 6, 2009

    Recall

    Recall Number
    Z-1661-2009
    Event Number
    53034
    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
    July 6, 2009
    Posted
    September 24, 2009
    Terminated
    December 16, 2011
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    LithoDiagnost

    Reason

    The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

    Action

    A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.

    Distribution

    Worldwide Distribution

    Quantity

    zero unit were distributed.