BEUDAMED
    FDA Recall Terminated

    Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).

    Recall: Z-0368-2007 · Initiated December 14, 2006

    Recall

    Recall Number
    Z-0368-2007
    Event Number
    37012
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2006
    Posted
    January 25, 2007
    Terminated
    October 14, 2011
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).

    Reason

    Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

    Action

    On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.

    Distribution

    Units were distributed to hospitals and medical centers nationwide.

    Quantity

    140 devices total