Olympus Scientific Solutions Americas Corporation — Class II medical device recall Z-0803-2016
Terminated recall by Olympus Scientific Solutions Americas, reported 2016-03-02, distributed nationwide. The Firm has discovered a Software bug.
| Recall number | Z-0803-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Scientific Solutions Americas, Waltham, MA, United States |
| Recall initiated | 2016-01-13 |
| Classified | 2016-02-19 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 5,000 units |
| Reason classes | software |
Product
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Reason for recall
The Firm has discovered a Software bug.
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-0803-2016. 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.