BEUDAMED
    FDA Recall Terminated

    Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.

    Recall: Z-0182-2012 · Initiated September 15, 2011

    Recall

    Recall Number
    Z-0182-2012
    Event Number
    60036
    Firm
    Philips Medical Systems
    FEI Number
    1525965
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 15, 2011
    Posted
    November 10, 2011
    Terminated
    January 30, 2013
    Address
    3860 N 1st St, San Jose, CA, 95134-1702

    Description

    Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.

    Reason

    A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.

    Action

    Philips sent all affected sites an Urgent Medical Device Correction Letter on September 27, 2011 for the MUGA issue. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy of the communication with the equipment instruction for use. Additionally, a field change order was released on September 26, 2011, customers will be receiving release notes as part of their correction informing them of the changes and corrections to the software. The new software will be installed on affected units by Philips Field Service Engineers. For customers in North America contact Customer Care Solutions Center at 1-800-722-9377. Select option 5. In all other countries contact the local Philips Healthcare office.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    1181 systems