Events

Recall of Device Recall Fujifilm Endoscope; ED530XT

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
    73469
  • Event Risk Class
    Class 2
  • Event Number
    Z-1860-2016
  • Event Initiated Date
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144249
  • 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
    This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures.
  • Action
    Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.

Device

Device Recall Fujifilm Endoscope; ED530XT
  • Model / Serial
    All distribution dates :3/2003-4/2016
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Endoscope; ED-530XT Operation Manual || 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
  • 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