FDA Device recall Z-1991-2015
Olympus Scientific Solutions Americas Analytical X-ray System
- FDA Device
- Class II
- ongoing
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of Olympus Scientific Solutions Americas Analytical X-ray System by Olympus Scientific Solutions Americas, citing 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 readi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1991-2015 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-06-09 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Olympus Scientific Solutions Americas |
| Distribution | US |
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
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).
Identifiers
| code_info | Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2015%22
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