BEUDAMED
    FDA Enforcement Class II Terminated

    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

    Recall: Z-1045-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1045-2017
    Event ID
    76187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DICOM GRID INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 25, 2017
    Initiation Date
    December 16, 2016
    Classification Date
    January 18, 2017
    Termination Date
    April 7, 2017
    Address
    4530 E Muirwood Dr, Ste. 113, Phoenix, AZ, 85048-7639, United States

    Description

    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

    Reason

    A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

    Distribution

    U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.

    Quantity

    209