| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00915-1 |
| Product Name/Description |
Philips HeartStart FR3, software version 2.0 (Automated external defibrillator (AED))
Model Numbers: 861388 and 861389
ARTG Number: 92346 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
HeartStart FR3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low. An AED running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customers to remove affected devices from service and to take the following action promptly:
- Upgrade all affected FR3 units following the instructions in the FR3 Software Upgrade Kit provided with the customer letter. This action has been closed-out on 18/04/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |