Events

Recall of Device Recall Dudenoscope

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
    72258
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2016
  • Event Initiated Date
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140362
  • 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
    A precautionary measure because the duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
  • Action
    FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8818. Customers with questions were instructed to contact their Fujifilm sales representative. For questions regarding this recall call 973-686-2482

Device

Device Recall Dudenoscope
  • Model / Serial
    Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107  Model Number: ED-200XT: Serial Number: 8681034  Model Number: ED-250XT: Serial Number: HD077A008  Model Number: ED-310XU: Serial Number: 8591013  Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026  Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022  Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100  Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020  Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
  • Product Description
    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
  • 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