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.
FDA Recall Z-1991-2015 · Posted 2015-07-31
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Recalling FirmOlympus Scientific Solutions Americas
Recall StatusOpen, Classified
Product CodeRBS
Date Initiated2015-06-09
Product Quantity1047
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).
Firm Action
Olympus Scientific Solutions planned action:
1. Notify product managers as to potential issues
2. Distribute new table and notice to instrument owners 30 JUL 15
3. Post new table on website for access 15 JUN 15
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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