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U.S. Department of Health and Human Services

Class 2 Device Recall Analytical XRay Fluorescence Systems of model family Delta

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  Class 2 Device Recall Analytical XRay Fluorescence Systems of model family Delta see related information
Date Initiated by Firm June 22, 2016
Create Date July 29, 2016
Recall Status1 Open3, Classified
Recall Number Z-2255-2016
Recall Event ID 74593
Product Classification X-ray fluorescence - Product Code RBY
Product Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence.

Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.

Code Information All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
Recalling Firm/
Manufacturer		 Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
For Additional Information Contact
866-446-6689
Manufacturer Reason
for Recall		 Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. The correction is via repair by a software update.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at ani.technicalsupport@olympus-ossa.com, phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.
Quantity in Commerce 2, 210 units distributed in the USA
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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