FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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.
- Recall number
- Z-2778-2015
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-06-30
- Posted
- 2015-09-17
- Terminated
- 2017-05-25
- Reason
- 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
- Device Design
- Action
- FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.
- Quantity
- 256 units
- Distribution
- Distributed in the US and Canada.
- Lot, serial or model codes
- ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
- 510(k) numbers
- ["K042076","K944620"]
- PMA numbers
- not on file
- Product code
- FDT
- 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