BEUDAMED
    FDA Enforcement Class II Terminated

    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable

    Recall: Z-1612-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1612-2015
    Event ID
    70890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    February 4, 2015
    Classification Date
    May 14, 2015
    Termination Date
    September 20, 2018
    Address
    419 West Ave, N/A, Stamford, CT, 06902-6343, United States

    Description

    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable

    Reason

    Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.

    Code Info

    Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

    Distribution

    Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.

    Quantity

    16 units