BEUDAMED
    FDA Recall Terminated

    Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)

    Recall: Z-0367-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-0367-2008
    Event Number
    44790
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 10, 2007
    Posted
    December 29, 2007
    Terminated
    September 19, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)

    Reason

    Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

    Action

    Consignees were notified of this recall by an Urgent Device Notification letter sent on 9/10/07. The letter instructed the users to not save any zoomed images to a batch file. Make all measurements of zoomed images in the CT viewer, which provides correct measurements. Do not perform measurements on any zoomed batched images that have been stored on a PACS System. Phillips in investigating the problem and will provide updates free of charge when completed.

    Distribution

    Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV, and WY, and country of Canada.

    Quantity

    2,544