BEUDAMED
    FDA Recall 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 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1045-2017
    Event Number
    76187
    Firm
    DICOM GRID INC
    FEI Number
    3008776294
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    December 16, 2016
    Posted
    January 18, 2017
    Terminated
    April 7, 2017
    Address
    4530 E Muirwood Dr, Ste. 113, Phoenix, AZ, 85048-7639

    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.

    Action

    On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action.

    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