Aizu Olympus Co., Ltd.: Olympus OER-Elite
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Aizu Olympus Co., Ltd.
- Product
- Olympus OER-Elite
- Reason / hazard
- Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-10-31
- Code info
- Model: OER-Elite; UDI: 04953170404047; Serial #: All;
- Product quantity
- 6578 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Aizuwakamatsu
- Country
- Japan
- Event id
- 97849
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