| TGA Action ID |
RC-2025-RN-01010-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Carestation 600 and 700 Series Anaesthesia Systems containing certain power management boards
Carestation 620 A1
Reference Number: 1012-9620-200
GTIN Number: 00195278439536
Carestation 650 A1
Reference Number: 1012-9650-200
GTIN Number: 00195278439529
Carestation 750 A1
Reference Number: 1012-9750-000
GTIN Number: 00840682145596 |
| ARTG Number |
93955 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential for unexpected shutdown of Carestation 600 and 700 Series Anaesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anaesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
If this situation is not identified and addressed by the user, the loss of ventilation may be life threatening. |
| Instructions for Customers/Users |
GE HealthCare will arrange for a representative to attend on site and correct impacted devices.
In the interim, customers can continue to use the machines by following the instructions in the customer letter. This includes:
- Promptly initiating ventilation using a self-inflating bag connected to an oxygen source, if there is a loss of AC mains power leading to an unexpected shutdown.
- Assess oxygenation via pulse oximetry.
- Supplement with or transition to intravenous anaesthetics as needed.
- Following system reboot, the system will enter pre-use check. Press "Start Anesthesia” or “Start Case” and then select the "Bypass" button to bypass the checkout. Select ventilation parameters and volatile agent concentration appropriate for the patient.
This action has been finalised on 25/09/2026. |
| Action Commencement Date |
4/12/2025 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare |