BEUDAMED
    FDA Recall Terminated

    Easy Access Image Management System with CL.Net.

    Recall: Z-0695-05 · Initiated February 16, 2005

    Recall

    Recall Number
    Z-0695-05
    Event Number
    31233
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 16, 2005
    Posted
    April 8, 2005
    Terminated
    February 13, 2006
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021

    Description

    Easy Access Image Management System with CL.Net.

    Reason

    Failure to update correctly when re-transmitting an image from the modality.

    Action

    The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.

    Distribution

    Devices distributed to hospitals and medical centers located throughout the U.S.

    Quantity

    60