FDA-Device2026-02-25Class I
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.
Olympus Corporation of the Americas
Hazard
Issue with software algorithm which may lead to overpressure events.
Sold states
Nationwide distribution
Affected count
485 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2026Original summary
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. Issue with software algorithm which may lead to overpressure events. Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers. Distribution: Nationwide distribution Affected quantity: 485 units
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