| TGA Action ID |
RC-2026-RN-00681-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Carestation 850 and 850c Anesthesia Systems
Carestation 850
REF:1012-9850-000
GTIN number: 00195278843593
Carestation 850c
REF:1012-9855-000
GTIN number: 00195278860859 |
| ARTG Number |
93955 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware of the potential unexpected shutdown of Carestation 800 Series Anesthesia Systems if the AC mains power is unplugged or AC mains power fails. This can occur following an incomplete system startup occurring when the ON/Standby switch is not pushed long enough as indicated in the User Reference Manual.
Due to this problem, if AC mains power is interrupted for any reason, the system could shut down disrupting gas flow, mechanical ventilation, manual ventilation, and anaesthetic agent delivery. If this is not promptly addressed by the user, the loss of ventilation can be life threatening.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
GE HealthCare will arrange for a representative to attend on site and correct impacted devices.
Pending the correction, customers can continue to use the machines by following the instructions in the Customer Letter. This includes:
1. Whenever possible, Carestation anesthesia systems should have mains power connected.
2. When turning on the system, push the On/Standy switch for 1 full second.
3. Complete all preoperative checkout tests in accordance with the instructions in the User Reference Manual.
4. If unexpected system shutdown occurs:
- Promptly initiate ventilation using a self-inflating bag connected to an oxygen source.
- Assess oxygenation via pulse oximetry.
- Supplement with or transition to intravenous anaesthetics, as needed, because anaesthetic agent delivery will be disrupted. |
| Action Commencement Date |
7/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |