Food, drugs, devices › Olympus Scientific Solutions Americas
Device recall: Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-
Olympus Scientific Solutions Americas (Waltham, MA) initiated this device recall on 9 Jun 2015; FDA lists 1 product record under event 71649, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Olympus Scientific Solutions Americas has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Olympus Scientific Solutions Americas, Waltham, MA.
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)."
Distribution
"Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1991-2015 | 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. | 1047 | Class II | Ongoing | 12 Aug 2015 |
Context
Other enforcement events for Olympus Scientific Solutions Americas
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Jul 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence | Device | Class II | 1 |
| 7 Jan 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical | Device | Class II | 1 |
| 27 Oct 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System | Device | Class II | 1 |
| 22 Jun 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence. Intended | Device | Class II | 1 |
| 13 Jan 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system | Device | Class II | 1 |
All 6 events for Olympus Scientific Solutions Americas
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.