FDA-Device2025-12-10Class II
Olympus OER-Elite
Aizu Olympus Co., Ltd.
Hazard
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Sold states
US Nationwide distribution.
Affected count
6578 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, Japan
Products
Olympus OER-Elite
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0872-2026Don't want to check this manually?
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