FDA-Device2025-12-10Class IIPROCESSING DEFECT
Olympus OER-Pro
Hazard
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
6578 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, Japan
Products
Olympus OER-Pro
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0873-2026Want us to check the next one for you?
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