Drug recall
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus…
FDA recall event 71649 · Class II · Olympus Scientific Solutions Americas
Key facts
| Event ID | 71649 |
|---|---|
| Recall numbers | Z-1991-2015 |
| Recalling firm | Olympus Scientific Solutions Americas |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 9, 2015 |
| Report date | Aug 12, 2015 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3010848881 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: