| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00819-1 |
| Product Name/Description |
Aisys CS2 Anaesthesia Systems: P/N: 1011-9050-000 – GTIN: 00840682102292
Avance CS2 and Avance CS2 Pro Anaesthesia Systems: P/N: 1009-9050-000 - GTIN: 00840682102322
ARTG 93955
(GE Healthcare Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
Certain Aisys CS2, Avance CS2, and Avance CS2 Pro Anaesthesia Systems manufactured from January 1, 2021 to April 23, 2022 can potentially have the O2 & Air cylinder pressure transducers reversed. The anesthesia system can display the O2 cylinder pressure reading as the Air cylinder pressure and the Air cylinder pressure reading as the O2 cylinder pressure. The correct gases are connected to each supply line, but the screen will display the cylinder pressures as reversed. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare ask customers to continue to use their Anaesthesia system by following the instructions given in the customer letter prior to its use.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1-800-659-465 - GE Healthcare Service |