Olympus - Insufflator, Endoscopic (japan)

Recalling firm: Olympus (NZ) Ltd
Product: Olympus - Insufflator, endoscopic (Japan). [Device]. Model: Unit models UHI, UHI-2, and UHI-3; Use available alternatives including an existing UHI-4 if available. Affected: All affected numbers -Olympus High Flow Insufflation Unit models - UHI, UHI-2, UHI-3 and N1000161. Also covers: UHI-4_High Flow Insufflator Unit
Reason: The manufacturer has determined that the software algorithm on High Flow Insufflation Unit, models UHI, UHI-2, and UHI-3, requires correction to address a potential issue which could lead to overpressure events. These events may occur due to an over insufflation of the abdominal cavity resulting from use of the UHI, UHI-2, or UHI-3 during patient procedures. This includes events where the device may not alarm or otherwise notify the user and/or may not relieve the over insufflation to the set pressure. Because no corrective solution is available, the manufacturer has decided to remove...
Classification: Class I
Category: medical device recall
Country: New Zealand
Agency: MEDSAFE
Recall date: 2026-01-26
Status: Ongoing
Distribution: New Zealand - Hospital/Pharmacy/Laboratory

Recall details on Nibble Recalls: https://trynibble.app/recalls/981f2b0d-142e-4b60-82a1-a4a5852f3c0e