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Class 2 Device Recall Xray Fluorescence |
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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
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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
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For Additional Information Contact |
781-419-3500
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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.
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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
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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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