Olympus Corporation of the Americas: Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke
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
- Olympus Corporation of the Americas
- Product
- Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
- Reason / hazard
- Issue with software algorithm which may lead to overpressure events.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide distribution
- Recall initiated
- 2026-01-16
- Code info
- Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
- Product quantity
- 485 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 98243
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