| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00582-1 |
| Product Name/Description |
Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2
Model Number: 90436A-07
ARTG Number: 135706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The monitored Minute Volumes (Vmin) are reported at ten times actual value on the bedside monitor. The source of this error is associated with a change in the Flexport communication protocol between versions 1.1 and 1.2. All alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. The reported x10 volumes would be an obvious error to the clinician. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016. |
| Contact Information |
1300 886 385 - Medtel Customer Support |