BEUDAMED
    FDA Recall Terminated

    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

    Recall: Z-2252-2014 · Initiated July 24, 2014

    Recall

    Recall Number
    Z-2252-2014
    Event Number
    68979
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 24, 2014
    Posted
    August 16, 2014
    Terminated
    February 11, 2016
    Address
    4100 E 3rd Ave, Ste 101, Foster City, CA, 94404-4819

    Description

    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

    Reason

    A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

    Action

    Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.

    Distribution

    US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

    Quantity

    109 units