BEUDAMED
    FDA Enforcement Class II Ongoing

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    Recall: Z-1818-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1818-2022
    Event ID
    90817
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DICOM Grid, Inc. d/b/a Ambra Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 5, 2022
    Initiation Date
    June 23, 2022
    Classification Date
    September 27, 2022
    Address
    450 Park Ave S Fl 10-111, N/A, New York, NY, 10016-7320, United States

    Description

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    Reason

    A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.

    Code Info

    UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.

    Distribution

    Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.

    Quantity

    671 downloads