BEUDAMED
    FDA Recall Terminated

    HD11XE Diagnostic Ultrasound System

    Recall: Z-0987-2007 · Initiated April 25, 2007

    Recall

    Recall Number
    Z-0987-2007
    Event Number
    37888
    Firm
    Philips Medical Systems
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 25, 2007
    Posted
    July 3, 2007
    Terminated
    January 24, 2011
    Address
    22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, WA, 98041-3003

    Description

    HD11XE Diagnostic Ultrasound System

    Reason

    Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib

    Action

    On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.

    Distribution

    Worldwide.

    Quantity

    219 units in US and 347 units distributed internationally