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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Scientific Solutions Americas Delta

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  Class 2 Device Recall Olympus Scientific Solutions Americas Delta see related information
Date Initiated by Firm June 09, 2015
Date Posted July 31, 2015
Recall Status1 Open3, Classified
Recall Number Z-1991-2015
Recall Event ID 71649
Product Classification Industrial x-ray - Product Code RBS
Product 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.
Code Information Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.
Recalling Firm/
Manufacturer		 Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
Manufacturer 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).
FDA Determined
Cause 2		 Component change control
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
Quantity in Commerce 1047
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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