Fujifilm Processor EPX 2500 High Definition Endoscopy — Class II medical device recall Z-2806-2015
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2015-09-30, distributed nationwide. The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to
| Recall number | Z-2806-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Wayne, NJ, United States |
| Recall initiated | 2015-06-30 |
| Classified | 2015-09-22 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
Product
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Reason for recall
The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2806-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.