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
    71695
  • Event Risk Class
    Class 2
  • Event Number
    Z-2778-2015
  • Event Initiated Date
    2015-06-30
  • Event Date Posted
    2015-09-17
  • 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=138763
  • 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
    The suction button on the ed-530xt endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ercp procedures.
  • Action
    FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.

Device

Device Recall FujiFilm
  • Model / Serial
    ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the US and Canada.
  • Product Description
    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
  • 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