Recall Z-2778-2015— Fujifilm Medical Systems U.S.A., Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-06-30, terminated 2017-05-25. It names 2 FDA 510(k) clearances: K042076, K944620. 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.. 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..
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-30
- Terminated
- 2017-05-25
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K042076 — FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
- K944620 — SERIES 400 GASTROENTEROLOGY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.