BEUDAMED
    FDA Recall Terminated

    AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.

    Recall: Z-0207-06 · Initiated October 12, 2005

    Recall

    Recall Number
    Z-0207-06
    Event Number
    33873
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2005
    Posted
    November 29, 2005
    Terminated
    March 9, 2011
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.

    Reason

    Potential for high voltage exposure involving the injector interface connector of patient support tables.

    Action

    On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

    Distribution

    Devices were distributed nationwide to hospitals/medical centers.

    Quantity

    529 units with MD6 tablets