Medical device recalls Moderate risk

Olympus Scientific Solutions Americas recalls Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM…

Recall date
June 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1991-2015
FDA classification
Class II
Brand / firm
Olympus Scientific Solutions Americas
Sold / distributed
Nationwide Distribution.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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