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U.S. Department of Health and Human Services

Class 2 Device Recall Xray Fluorescence

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  Class 2 Device Recall Xray Fluorescence see related information
Date Initiated by Firm January 07, 2017
Create Date February 01, 2017
Recall Status1 Terminated 3 on August 27, 2019
Recall Number Z-1036-2017
Recall Event ID 76208
Product Classification X-ray fluorescence - Product Code RBY
Product Olympus Scientific Solutions Americas Corporation
(OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR
Analytical X-ray systems
Code Information affects all units.
Recalling Firm/
Manufacturer		 Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
For Additional Information Contact
781-419-3500
Manufacturer Reason
for Recall		 It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Olympus will bring the defect 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 recall 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) 419-3500.
Quantity in Commerce US 74
Distribution US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
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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