Recall Z-2760-2017— Olympus Scientific Solutions Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Scientific Solutions Americas, initiated 2017-07-11, terminated 2023-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence. Reason: 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)..
- Recalling firm
- Olympus Scientific Solutions Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-11
- Terminated
- 2023-05-03
- Firm location
- Waltham, MA, United States
Product description
Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.