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U.S. Department of Health and Human Services

Class 2 Device Recall DELTA XRF analyzer

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  Class 2 Device Recall DELTA XRF analyzer see related information
Date Initiated by Firm January 13, 2016
Create Date February 19, 2016
Recall Status1 Open3, Classified
Recall Number Z-0803-2016
Recall Event ID 73251
Product Classification X-ray fluorescence - Product Code RBY
Product Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Code Information All models of the Delta XRF Analyzer
Recalling Firm/
Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
For Additional Information Contact
Manufacturer Reason
for Recall
The Firm has discovered a Software bug.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Olympus Scientific Solutions Americas ( OSSSA) planned action to bring product into compliance: Notification will be given to purchasers per 21 CFR 1003.21. A software modification will be made available to all users contacted. The letter to affected purchasers makes clear that the product will be brought into compliance without charge and offers the purchaser several options for applying the software update. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number- controlled downloads, follow-up email reporting, return-mail card or some other similarly effective means. For further questions you may call : (866) 446-6689.
Quantity in Commerce US - 5000 units
Distribution Worldwide Distribution - USA (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.