| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00267-1 |
| Product Name/Description |
Philips HeartStart FR3
Model numbers: 861388 and 861389
Serial numbers: C13F-00539, C13F-00580
ARTG Number: 92346 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
In a limited number of FR3 AEDs, the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event that PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to continue to use the AED if there are no alternatives available. Customer who have the affected device will be supplied with a replacement AED from Philips. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |