BEUDAMED
    FDA Enforcement Class II Ongoing

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    Recall: Z-1172-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1172-2024
    Event ID
    93855
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FUJIFILM Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    January 3, 2024
    Classification Date
    February 21, 2024
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    Reason

    The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.

    Code Info

    UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

    Distribution

    US domestic distribution nationwide. International distribution to Israel.

    Quantity

    8