BEUDAMED
    FDA Recall Terminated

    General X-Ray System types with Digital Spot Imaging (DSI) software

    Recall: Z-2160-2008 · Initiated May 23, 2008

    Recall

    Recall Number
    Z-2160-2008
    Event Number
    48602
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 23, 2008
    Posted
    August 25, 2008
    Terminated
    September 28, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    General X-Ray System types with Digital Spot Imaging (DSI) software

    Reason

    X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).

    Action

    On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.

    Distribution

    Nationwide Distribution.

    Quantity

    41 units