FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
- Recall number
- Z-2805-2015
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
- Status
- Terminated
- Initiated
- 2015-06-30
- Posted
- 2015-09-22
- Terminated
- 2017-05-25
- Reason
- 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
- 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
- 60
- Distribution
- Nationwide US and Canada
- Lot, serial or model codes
- Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E
- 510(k) numbers
- ["K944759"]
- PMA numbers
- not on file
- Product code
- FET
- Firm FEI
- 2431293
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28