FDA-Device2015-08-12Class II
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.
Olympus Scientific Solutions Americas
Hazard
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).
Sold states
Nationwide Distribution.
Affected count
1047
Manufactured in
48 Woerd Ave, N/A, Waltham, MA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1991-2015Don't want to check this manually?
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