Z-1991-2015 Class II Ongoing
FDA device recall Z-1991-2015 was initiated by Olympus Scientific Solutions Americas on June 9, 2015 and is designated Class II. 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. Howe… The recall status is ongoing. Affected quantity: 1047.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2015
- Initiation Date
- June 9, 2015
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1047
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).
Distribution Pattern
Nationwide Distribution.
Code Information
Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.