BEUDAMED
    FDA Recall Terminated

    MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502

    Recall: Z-1307-04 · Initiated June 8, 2004

    Recall

    Recall Number
    Z-1307-04
    Event Number
    29470
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2004
    Posted
    August 4, 2004
    Terminated
    February 9, 2006
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021

    Description

    MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502

    Reason

    When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

    Action

    The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.

    Distribution

    Philips Medical Systems North American Company distributes product to medical facilities nationwide.

    Quantity

    8