Device product

Olympus OER-Pro

Z-0873-2026

October 31, 2025

Class II

Product summary

Firm: Aizu Olympus Co., Ltd.
Event: Event 97849
Status: Ongoing
Classification: Class II
Quantity: 6578 units
Official record key: device-enforcement:Z-0873-2026

Official wording

Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Code information: Model: OER-Pro; UDI: 04953170258589; Serial #: All;

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.