| TGA Action ID |
RC-2025-RN-00797-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hugo RAS system - Initial Launch Instruments
Model Numbers: MRASI0007, MRASI0012
GTIN: 10884521740006, 10884521740051
Year (First 3 Digits): C21
ID (Second 3 Digits): BAE, BAH
Range (Last 4 Digits): All
All serial numbers |
| ARTG Number |
377600, 378145 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When an Initial Launch Instrument is attached to a Hugo RAS system running software version 2.2 or higher, the system may display the message: “Instrument expired. Detach instrument and replace.” This problem occurs upon attachment and can be immediately resolved by replacing the affected instrument.
Medtronic has received 9 complaints related to this problem, with no reports of harm to either the patient or user. The potential risks include the inability to use an affected instrument, which could lead to a delay in treatment (i.e. prolonged procedure) and/or bleeding. |
| Instructions for Customers/Users |
Customers are to:
• immediately quarantine and discontinue use of the affected Initial Launch Instruments with associated serial numbers, listed in Appendix A of the customer letter.
• return all affected products. Medtronic will assist with the return of affected products upon request.
Medtronic will work with customers to ensure that replacement instruments are available to prevent interruptions in patient care.
This action has been finalised on 21/01/2026. |
| Action Commencement Date |
16/09/2025 |
| Responsible Entity |
|
| Contact Information |
0486 006 068 - Glen Kuhn, Medtronic Australasia |