FDA recall Z-2760-2017

Olympus Scientific Solutions Americas · Class II · device

Product

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).

Distribution

Worldwide Distribution - USA (nationwide) Distribution

Key facts

Status
Terminated
Initiation date
2017-07-11
Report date
2017-08-09
Termination date
2023-05-03
Voluntary/Mandated
FDA Mandated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2760-2017