Recall Z-1991-2015— Olympus Scientific Solutions Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Scientific Solutions Americas, initiated 2015-06-09. FDA's recall record names no specific 510(k) clearance for this event. 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)..
- Recalling firm
- Olympus Scientific Solutions Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2015-06-09
- Firm location
- Waltham, MA, United States
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.