BEUDAMED
    FDA Recall Terminated

    Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021

    Recall: Z-0330-2008 · Initiated September 24, 2007

    Recall

    Recall Number
    Z-0330-2008
    Event Number
    44959
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 24, 2007
    Posted
    December 7, 2007
    Terminated
    May 3, 2012
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021

    Reason

    Inaccurate anatomical measurements when using the optional SmartMask feature

    Action

    The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.

    Distribution

    Nationwide

    Quantity

    53 units