| TGA Action ID |
RC-2026-RN-00727-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Aisys CS2, Aisys CS2 with Et Control and S/5 Aisys Anesthesia Systems
Aisys CS2
Reference number: 1011-9050-000
Aisys CS2 With Et Control
Reference number: 1011-9055-000
Aisys
Reference number: 1011-9000-000
Affected Field Replaceable Units (FRU) parts:
Gas Mixer Electronic – Assembly
Item Number: 1011-8000-000-S
R-FMI34141 GAS MIXER ELECTRONIC
Item Number: 5700665
Lot/Serial Number Date Range: November 13, 2025, to June 2, 2026 |
| ARTG Number |
93955 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a risk that the affected anesthesia delivery systems can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms (“Set Alt O2 Flow! Agent delivery off!” or “Set Alt O2 flow! Check agent setting!”). When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
To date, there have been 7 complaints reported to GE HealthCare related to this problem, with no injuries reported. |
| Instructions for Customers/Users |
GE HealthCare will arrange a time to inspect and correct as necessary all affected products.
In the interim, customers may continue to use the anesthesia systems by following the advice in the customer letter, including:
- Prior to each use, complete preoperative checkout and tests in accordance with the instructions in the user manual.
- When Alternate O2 control is enabled, the clinician should adjust the Alternate O2 flow as appropriate for the case. Use the Alternate O2 control knob to adjust the O2 flow.
- When Alternate O2 control is enabled, flow from the electronic mixer is stopped and the agent concentration is set to off. Two situations are possible regarding the Agent quick key:
a. The Agent quick key will be blank on the display if agent delivery is unavailable. Supplement with or transition to intravenous anesthetics as needed.
b. The Agent quick key will be present on the display if agent delivery can be resumed. Press the Agent quick key to set the desired concentration and press the key again to confirm.
- Evaluate existing service stock for the FRU spare parts listed, and dispose of all affected FRU parts according to their facility procedures. |
| Action Commencement Date |
23/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |