BEUDAMED
    FDA Recall Terminated

    Envisor, M2540 Diagnostic Ultrasound System

    Recall: Z-0923-05 · Initiated May 13, 2005

    Recall

    Recall Number
    Z-0923-05
    Event Number
    32196
    Firm
    Philips Ultrasound, Inc.
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2005
    Posted
    June 22, 2005
    Terminated
    May 9, 2008
    Address
    22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, WA, 98041-3003

    Description

    Envisor, M2540 Diagnostic Ultrasound System

    Reason

    A defect in the software allows incorrect measurement results to be entered into the system's built-in report.

    Action

    On May 13, 2005 the firm mailed a letter to their customers advising of the problem and that a local representative will visit each site to perform a software upgrade.

    Distribution

    Units were distributed nationwide to hospitals and medical centers and internationally.

    Quantity

    194