BEUDAMED
    FDA Recall Terminated

    Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035

    Recall: Z-0676-2008 · Initiated September 28, 2007

    Recall

    Recall Number
    Z-0676-2008
    Event Number
    45329
    Firm
    Phillips Nuclear Medicine
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 28, 2007
    Posted
    February 8, 2008
    Terminated
    February 4, 2009
    Address
    540 Alder Dr, Bldg 4, Milpitas, CA, 95035-7443

    Description

    Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035

    Reason

    Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.

    Action

    A Customer Advisory Notification was mailed to affected consignees on September 28, 2007. The firm informed consignees that incorrect measurement can occur when the Cardiac Viewer or Pulmonary Viewer is used to zoom and save derived images in batch files. The firm provided instructions for operators to prevent incorrect measurements. Phillips is currently investigating methods to correct this issue and will provide updates, free of charge, when they become available. If you have questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnostic Imaging, option 5:NM).

    Distribution

    Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.

    Quantity

    19