BEUDAMED
    FDA Recall Terminated

    BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.

    Recall: Z-0905-2011 · Initiated January 17, 2011

    Recall

    Recall Number
    Z-0905-2011
    Event Number
    58077
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 17, 2011
    Posted
    March 4, 2011
    Terminated
    August 11, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.

    Reason

    Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.

    Action

    A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.

    Distribution

    Worldwide Distribution

    Quantity

    1810 units in the US