BEUDAMED
    FDA Recall Terminated

    Allura Xper FD 20/10 x-ray, and fluoroscopy

    Recall: Z-0166-2007 · Initiated October 12, 2006

    Recall

    Recall Number
    Z-0166-2007
    Event Number
    36573
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2006
    Posted
    November 14, 2006
    Terminated
    September 24, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Allura Xper FD 20/10 x-ray, and fluoroscopy

    Reason

    Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.

    Action

    On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.

    Distribution

    Nationwide.

    Quantity

    19 devices