Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450X
FDA device recall Z-2778-2015 · posted 2015-09-17 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- 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.
- Action taken
- FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FDT
- Quantity affected
- 256 units
- Distribution
- Distributed in the US and Canada.
- Date initiated
- 2015-06-30
- Date posted
- 2015-09-17
- Date terminated
- 2017-05-25
- Location
- Wayne, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 (K042076) | Fujinon, Inc. | 2004-11-18 |
| SERIES 400 GASTROENTEROLOGY SYSTEM (K944620) | Marks & Murase | 1995-04-27 |