Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
- Recall Initiated
- July 11, 2017
- Terminated
- May 3, 2023
- Recall Number
- Z-2760-2017
- Quantity
- 146 units
- Firm Location
- Waltham, MA
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).
Distribution
Worldwide Distribution - USA (nationwide) Distribution
Lot / Code Info
Models : VCR and VMR.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.