BEUDAMED
    FDA Enforcement Class II Terminated

    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    Recall: Z-0225-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0225-2016
    Event ID
    72472
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    September 28, 2015
    Classification Date
    November 5, 2015
    Termination Date
    April 11, 2018
    Address
    540 W Northwest Hwy, N/A, Barrington, IL, 60010-3051, United States

    Description

    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    Reason

    Inaccurate distance measurements with magnified projection X-ray images.

    Code Info

    2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.

    Quantity

    Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units