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Recall Observatory FDA recall evidence

Device product

Olympus OER-Elite

Z-0872-2026

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-0872-2026

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-Elite; UDI: 04953170404047; 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.