Events

Recall of Device Recall Fujifilm

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
    71706
  • Event Risk Class
    Class 2
  • Event Number
    Z-2805-2015
  • Event Initiated Date
    2015-06-30
  • Event Date Posted
    2015-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138794
  • 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
    Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
  • Reason
    The epx-2500 operation manual and sales brochure incorrectly identify that the ed-530xt endoscope is meant to be used with the epx-2500 processor. the operation manual and sales brochure state that when the ed-530xt endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
  • Action
    Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers.

Device

Device Recall Fujifilm
  • Model / Serial
    Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide US and Canada
  • Product Description
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
  • 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., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA