BEUDAMED
    FDA Enforcement Class II Ongoing

    Synapse PACS Software Versions 5.1 and higher

    Recall: Z-0878-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0878-2021
    Event ID
    86532
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2021
    Initiation Date
    September 11, 2020
    Classification Date
    January 16, 2021
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    Synapse PACS Software Versions 5.1 and higher

    Reason

    There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

    Code Info

    Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.

    Distribution

    Software was distributed to medical facilities nationwide throughout the U.S.

    Quantity

    235