Device product
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Z-1352-2026
Product summary
- Event
- Event 98243
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1352-2026
Official wording
Reason: Issue with software algorithm which may lead to overpressure events.
Code information: Model Number: UHI; UDI-DI: N/A; All Serial Numbers
Distribution pattern: Nationwide distribution
Derived failure modes
-
Device software or design
Issue with software