Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
- Recall Initiated
- January 7, 2017
- Terminated
- August 27, 2019
- Recall Number
- Z-1036-2017
- Quantity
- US 74
- Firm Location
- Waltham, MA
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.
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.
Lot / Code Info
affects all units.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.