BEUDAMED
    FDA Recall Terminated

    Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

    Recall: Z-1449-2013 · Initiated January 16, 2013

    Recall

    Recall Number
    Z-1449-2013
    Event Number
    64128
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    January 16, 2013
    Posted
    June 17, 2013
    Terminated
    October 15, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

    Reason

    An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

    Action

    Philips Healthcare issued an Urgent Field Safety Notification on January 11, 2013, to advised users of issued and perform corrective action to the units. Field Service Engineer (FSE) will execute corrections and attach record to IATD file. Your proposed corrective action plan (CAP) for the Bucky Diagnost system involves two mandatory field actions including new testing for sites with missing documentation and correcting the table height measurements for systems where the incorrect measurement procedure was used. You have also revised your IATD document to improve instructions to the field engineer for table height measurements. In your March 28, 2013, letter, you proposed a 6 month timeframe for this corrective action, and in your May 9, 2013 email, you communicated that the field corrections were ongoing and would be completed by July 16, 2013. In your May 9, 2013 email, you also clarified that the recalls are to be completed free of charge to any affected customer, whether or not they have a service agreement with Philips Healthcare. Further questions please call (978) 687-1501.

    Distribution

    Worldwide Distribution - US Nationwide and the country of Canada.

    Quantity

    66 units