FDA Device recall Z-2778-2015
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Fujifilm Medical Endoscope for the duodenum and upper G.I. tract by Fujifilm Medical Systems U, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2778-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | n/a |
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.
Identifiers
| code_info | ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2778-2015%22
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