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.