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
    76905
  • Event Risk Class
    Class 2
  • Event Number
    Z-3129-2017
  • Event Initiated Date
    2015-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155284
  • 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
    Duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Reason
    Fujifilm is conducting a corrective action due to an fda inspection.
  • Action
    Fujifilm notified their customers on 3/9/2015. Customers are advised of the updated manuals. and asked to destroyed existing manuals. Questions, comments and concerns should be directed to 800.385.4666 between the areas of 8:00 am and 5:00 pm EST or via email at G5info@fujifilm.com.

Device

Device Recall Fujifilm
  • Model / Serial
    will be entered.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Fujifilm Endoscope || Models || ED-250XL5 || ED-250XT5 || ED-450XT5 || ED-450XL5 || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
  • 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