| TGA Action ID |
RC-2026-RN-00055-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus High Flow Insufflation Unit and UHI-3 INSUFFLATOR BUILT-IN SMOKE EVAC
Models: UHI, UHI-2, UHI-3
SKU: N1000161
All lot numbers
ARTG 146430 (Cancelled as of 16/08/2019) |
| ARTG Number |
211802 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The software algorithm on the High Flow Insufflation Unit, models UHI, UHI-2, and UHI-3 has a potential problem which could lead to overpressure events. These events may occur due to an over insufflation of the abdominal cavity 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, Olympus has decided to remove these models from the market. |
| Instructions for Customers/Users |
Customers are to:
• Immediately cease using any UHI, UHI-2, and/or UHI-3 in their inventory and quarantine to prevent further use.
• Use alternatives including an existing UHI-4 if available, or switching to an insufflation device from another manufacturer.If no alternative is available on site, contact Olympus to discuss alternative solutions.
• Complete the Customer Response Form immediately even if they do not have any affected stock, and return it to oaz-fca@olympus.com
After receiving the response form, Olympus will reach out to coordinate the return of the devices. An Olympus local sales representative will contact customers separately to discuss available solutions. |
| Action Commencement Date |
30/01/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |