Events

Recall of Device Recall Fujinon/Fujifilm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujinon 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
    66144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0112-2014
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121946
  • 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
    Gastroscope and accessories, flexible/rigid - Product Code FDS
  • Reason
    A limited number of endoscopes were shipped to fmsu-esd with a manufacturing defect which included missing set screws used to more securely attach the forceps inlet (biopsy inlet port) to the endoscope.
  • Action
    The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an "URGENT-MEDICAL DEVICE CORRECTION (UMDC)" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached "Customers Acknowledgement" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: gwalljasper@fujifilm.com. If you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: gwalljasper@fujifilm.com.

Device

Device Recall Fujinon/Fujifilm
  • Model / Serial
    Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
  • Product Description
    Fujinon/Fujifilm Ultrasonic Endoscope || Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
  • Manufacturer
    Fujinon Inc

Manufacturer

Fujinon Inc
  • Manufacturer Address
    Fujinon Inc, 10 Highpoint Dr, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA