| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00683-1 |
| Product Name/Description |
Avance CS2 and Avance CS2 Pro anesthesia devices
ARTG 93955
(GE Healthcare Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare Australia advise of a potential battery issue can result in premature shutdown of the anesthesia device in situations where AC mains power is lost and back up emergency power is not available
Anesthesia systems only operate on battery power in a rare event that AC mains power shuts off and there is no backup emergency power. If this situation is not identified and addressed by the attending clinician, the loss of ventilation may be life threatening.
The issue affects backup batteries in Avance CS2 and Avance CS.2 Pro anesthesia devices manufactured on or after April 1, 2019, and GE Healthcare recommended field replacement batteries distributed on or after April 1, 2019, for Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View can potentially fail earlier than their estimated life.
There have been no reports of battery depletion occurring during patient use and no injuries have been reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare note that customers:
1. Can continue to use the affected anesthesia device while the device is connected to an AC mains power source that is supported by backup emergency power.
2. Advise that if this issue occurs, use the integrated manual ventilation and oxygen delivery features of the device.
3. Immediately perform the Battery Performance Test as described in the customer letter and replace the batteries, when necessary, before patient use.
4. When not in patient use, the device should always remain connected to the AC mains power source to prevent battery discharge and degradation. |
| Contact Information |
1800 659465 -GE Healthcare Service |