| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01134-1 |
| Product Name/Description |
Hamilton Medical C3 Ventilator
Serial Numbers: 1100, 2037
ARTG Number: 194271 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified an issue related to SpO2 monitoring with the use of the Hamilton-C3 ventilator. When measuring SpO2, the software of the Hamilton-C3 can run into a system or CPU overload causing a screen freeze. The alarm buzzer sounds and the device needs to be reset. In case of such a system or CPU overload, the Hamilton-C3 stops the ventilation and sounds the alarm buzzer. However, since the screen freezes, no alarm message is displayed to the operator. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
All the Hamilton-C3 ventilators have SpO2 option deactivated by default as there are no SpO2 sensors in use in Australia. The new software version 2.0.2 will be installed as a permanent correction. This action has been closed-out on 15/02/2017. |
| Contact Information |
03 9330 4940 - Taleb Medical |