BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2252-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2252-2014
    Event ID
    68979
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Informatics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 24, 2014
    Classification Date
    August 15, 2014
    Termination Date
    February 11, 2016
    Address
    4100 E 3rd Ave Ste 101, Foster City, CA, 94404-4819, United States

    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.

    Code Info

    IntelliSpace 4.4

    Distribution

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

    Quantity

    109 units