Events

Recall of Device Recall FujiMedical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical Systems U.S.A., Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70891
  • Event Risk Class
    Class 2
  • Event Number
    Z-1611-2015
  • Event Initiated Date
    2015-02-04
  • Event Date Posted
    2015-05-14
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135415
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer, diagnostic, programmable - Product Code DQK
  • 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.

Device

Device Recall FujiMedical
  • Model / Serial
    Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
  • Product 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
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA