BEUDAMED
    FDA Recall Terminated

    iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.

    Recall: Z-1141-2008 · Initiated January 4, 2008

    Recall

    Recall Number
    Z-1141-2008
    Event Number
    46414
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 4, 2008
    Posted
    May 8, 2008
    Terminated
    October 7, 2009
    Address
    4100 East Third Avenue, Suite 101, Foster City, CA, 94404

    Description

    iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.

    Reason

    Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.

    Action

    Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.

    Distribution

    Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.

    Quantity

    197 units