Z-2805-2015Class II

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures

Name: Z-2805-2015 Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures
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 Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures on 2015-06-30. FDA classified it as Class II and gives the reason as "The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT...". 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-2805-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2015-09-22
Terminated: 2017-05-25
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Product code: FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Reason for recall: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
Root cause tag: design
FDA root cause: Device Design
Action: Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers.
Quantity in commerce: 60
Distribution: Nationwide US and Canada
Product codes and lots: Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2805-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2805-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-22
Z-2806-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-22

Product code FET

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)