Olympus Scientific Solutions Americas Analytical X-ray System — Class II medical device recall Z-1991-2015
Ongoing recall by Olympus Scientific Solutions Americas, reported 2015-08-12, distributed nationwide. Higher than published scatter around the probe head when testing some samples. At the point the customer would
| Recall number | Z-1991-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Scientific Solutions Americas, Waltham, MA, United States |
| Recall initiated | 2015-06-09 |
| Classified | 2015-07-31 |
| Reported by FDA | 2015-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,047 |
Product
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
Reason for recall
Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).
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-1991-2015. 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.