BEUDAMED
    FDA Recall Terminated

    Allura Xper FD10/10 x-ray system

    Recall: Z-0581-06 · Initiated February 6, 2006

    Recall

    Recall Number
    Z-0581-06
    Event Number
    34602
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2006
    Posted
    February 28, 2006
    Terminated
    May 20, 2008
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Allura Xper FD10/10 x-ray system

    Reason

    Potential lock-up of system requiring reboot of system.

    Action

    On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices.

    Distribution

    Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.

    Quantity

    55 devices total (Allura Xper FD10/10 & Allura Xper FD10)