BEUDAMED
    FDA Recall Terminated

    Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Recall: Z-2207-2011 · Initiated March 7, 2011

    Recall

    Recall Number
    Z-2207-2011
    Event Number
    58510
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2011
    Posted
    May 19, 2011
    Terminated
    February 22, 2013
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Reason

    A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.

    Action

    A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.

    Distribution

    Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.

    Quantity

    5 units