FDA Device recall Z-3225-2017
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation…
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation… by Fujifilm Medical Systems U, citing an update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3225-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Reason
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Identifiers
| code_info | All lots/serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3225-2017%22
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