Z-0418-2016Class II

Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL...

Name: Z-0418-2016 Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-08-31
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-08-31 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of 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... on 2015-08-31. FDA classified it as Class II and gives the reason as "A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0418-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-12-15
Terminated: 2018-03-21
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Root cause tag: design
FDA root cause: Device Design
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
Quantity in commerce: 79 units (US) and 985 units (Internationally)
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15

Product code FDT

K944759Class II200 Series Gastro-Intestinal Video SystemFujinon, Inc. / cleared 1995-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)