Z-2778-2015Class II

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5...

Name: Z-2778-2015 Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-06-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-06-30 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of 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 on 2015-06-30. FDA classified it as Class II and gives the reason as "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". 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-2778-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2015-09-17
Terminated: 2017-05-25
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.
Quantity in commerce: 256 units
Distribution: Distributed in the US and Canada.
Product codes and lots: ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2778-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2778-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-17

Product code FDT

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)