| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00211-1 |
| Product Name/Description |
LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED)
ARTG Number: 124228 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
In some rare situations, the CHARGE-PAK replaceable battery charger has not lasted two years because of an internal electrical failure that leads to early internal battery depletion. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are instructed to continue to monitor the AED routinely for warning indicators as stated in the instructions for use. If it is determined that the device is affected by the early battery depletion issue a permanent replacement device will be provided. This action has been closed-out on 04/04/2017. |
| Contact Information |
02 9415 5904 - Physio Control Australia Pty Ltd |