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U.S. Department of Health and Human Services

Class 2 Device Recall VANTA Analytical XRay System, X Ray Fluorescence

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  Class 2 Device Recall VANTA Analytical XRay System, X Ray Fluorescence see related information
Date Initiated by Firm July 11, 2017
Create Date August 02, 2017
Recall Status1 Terminated 3 on May 03, 2023
Recall Number Z-2760-2017
Recall Event ID 77759
Product Classification X-ray fluorescence - Product Code RBY
Product Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
Code Information Models : VCR and VMR.
Recalling Firm/
Manufacturer		 Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
For Additional Information Contact
781-419-3900
Manufacturer Reason
for Recall		 Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Olympus Scientific Solutions Americas Corp will bring defect into compliance: 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-tracked downloads, follow-up email reporting, return- mail card or by other similarly effective means. For further questions, please call (781) 419-3900.
Quantity in Commerce 146 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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