Fujifilm Endoscope Model ED-530XT Product Usage: This product is a… — Class II medical device recall Z-3128-2017
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2017-09-20, distributed nationwide. Fujifilm is reporting a corrective action due to an FDA inspection.
| Recall number | Z-3128-2017 |
|---|---|
| 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 | 2015-03-09 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 260 manuals |
| Model numbers | ED-530XT |
Product
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Reason for recall
Fujifilm is reporting a corrective action due to an FDA inspection.
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-3128-2017. 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.