BEUDAMED
    FDA Recall 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 · Initiated April 30, 2021

    Recall

    Recall Number
    Z-1775-2021
    Event Number
    87938
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 30, 2021
    Terminated
    July 29, 2024
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    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

    Action

    Fujifilm issue consignee notifications via email on April 30, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY CUSTOMER/END USER FUJIFILM will offer an upgrade to Synapse CV 6.2.2 to resolve this issue. FUJIFILM recommends the following actions: 1) Complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken. 2) Contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a ticket for the upgrade. Until your upgrade is scheduled and completed, Advanced Reporting users can continue to safely use Synapse CV by choosing one of the following options: 1) Merge the older patient record to the newer patient record, and then delete the older patient record. This sequence retains the most recent internal patient database ID and deletes an older internal patient database ID that will not be erroneously reassigned. 2) Merge the newer patient record to the older patient record only after additional new patients have been added beyond the record you want to merge. This sequence ensures that the most recent internal patient database ID is assigned to a record that is not involved in the merge activity. 3) Always check patient information presented in the report with other information provided for that patient/study. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at [email protected], if you have any further questions regarding this field action.

    Distribution

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

    Quantity

    44 US and 4 OUS