BEUDAMED
    FDA Recall Terminated

    FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

    Recall: Z-1611-2015 · Initiated February 4, 2015

    Recall

    Recall Number
    Z-1611-2015
    Event Number
    70891
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    February 4, 2015
    Posted
    May 14, 2015
    Terminated
    September 20, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

    Reason

    Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

    Action

    FujiMedical Systems North America issued intial recall letter dated February 4, 2014, advising users of the HL7 report exported to the EMR wherein measurement values presented in the Hl7 reports in your EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Follow-up letters were issued February 12, 2014, and July 24, 2014. A mandatory upgrade to software version 5.1.1/ base, in-place upgrade required. A customer response form attached to acknowledge receipt and arrange for the on site upgrade. For questions regarding this recall call 203-324-2000.

    Distribution

    Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada

    Quantity

    30 units