BEUDAMED
    FDA Enforcement Class II Terminated

    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system

    Recall: Z-1775-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1775-2021
    Event ID
    87938
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 30, 2021
    Classification Date
    June 2, 2021
    Termination Date
    July 29, 2024
    Address
    81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States

    Description

    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system

    Reason

    Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence

    Code Info

    Software Versions: 6.0 to 6.2.1

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.

    Quantity

    44 US and 4 OUS