BEUDAMED
    FDA Recall 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 · Initiated February 4, 2015

    Recall

    Recall Number
    Z-1612-2015
    Event Number
    70890
    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

    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.

    Action

    Fujifilm Medical on 2/4/14 , contacted users and advised to discontinue using HL7 reports pending FMSU determination of root cause. Firm issued follow-up letters on 2/24/14 and 7/24/14 advising users of a mandatory upgrade to version 5.1.1 I base, in-place upgrade, to correct the problems.

    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