FDAJune 9, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Ongoing

Brands named

olympus scientific solutions americasolympusolympus scientific

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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