BEUDAMED
    FDA Recall Terminated

    Interis Allura BiPlane X-Ray System

    Recall: Z-0022-06 · Initiated July 27, 2005

    Recall

    Recall Number
    Z-0022-06
    Event Number
    33014
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 27, 2005
    Posted
    August 31, 2005
    Terminated
    May 20, 2008
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Interis Allura BiPlane X-Ray System

    Reason

    1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.

    Action

    A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed.

    Distribution

    Devices were distributed to hospitals/medical centers nationwide.

    Quantity

    43 units