| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01406-1 |
| Product Name/Description |
Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed
Part Number of large tray insert : 1009-3260-000
ARTG Number: 93955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anaesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory, is closed with an abnormally high amount of force. Should the anaesthesia device transition to a System Malfunction state the device will perform in the following manner:
- Automatically activate Alternate Oxygen flow within a few seconds,
- Provide high priority audible and visible alarms,
- Provide on display instructions to set the oxygen (O2) flow and manually ventilate the patient,
- Continue to deliver anaesthetic agent at the existing vaporizer setting.
If the System Malfunction is left unresolved, it could result in loss of patient ventilation potentially resulting in hypoxia. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is advising users that they can continue to use their Avance CS2, Avance, and Amingo devices after the optional large tray insert accessory has been removed. Customers are requested to destroy all large tray inserts in their possession.However, customers should contact GE if they choose to return the tray insert. This action has been closed-out on 18/05/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |