| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00025-1 |
| Product Name/Description |
HAMILTON-T1 Transport Ventilator, Software version 1.1.2
Model Number: T1
Multiple serial numbers affected
ARTG Number: 187874 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Higher than expected internal oxygen consumption of the Hamilton T1 transport ventilator may cause miscalculation of the required oxygen supply for paediatric patient transport situations with long timeframe applications where the oxygen supply may be limited or finite. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AHC Solutions Pty Ltd (the sponsor) is providing amended instructions describing the process required to calculate the correct oxygen requirement prior to transport. Hamilton Medical (the manufacturer) will provide a software update to correct the issue. |
| Contact Information |
02 9980 9669 - AHC Solutions |