| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00087-2 |
| Product Name/Description |
HeartStart Automated External Defibrillator (AED)
Models affected : FRx and HS1
All serial numbers affected
ARTG Number: 95661 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
31/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips is providing additional instructions for use to advise the user of the correct actions to take in the event an error notification:
-If the FRx or HS1 AED emits a pattern of 'single chirps' please press the blue i-button on the front of the device. The AED will tell exactly what actions
to take to ensure that the device is ready for use.
-If at any time during the life of the device, the FRx or HS1 AED emitted or begins to emit a pattern of 'triple chirps', it is important that the
device is removed from use and a Philips representative is contacted. It is a signal that the device requires investigation by Philips to ensure that it is
ready for use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing additional instructions advising users to contact Philips technical support if a device error occurs and the device begins to emit a triple chirp, even if the error can be cleared. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |