| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00208-1 |
| Product Name/Description |
Wireless Link for HeartStart MRx Monitor/Defibrillator
Serial Numbers: US00100253 and US00561724
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
25/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Wireless Link may be unable to trasmit data when configured for a specific data flow. This specific condition may only occur when the Wireless Link is configured to operate in access point mode in Data Management. If this occurs, the MRx user will be informed of this inability to transmit data via visual notifications on MRx. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will be installing a software update to correct the issue. Philips is advising MRx users that while awaiting for the software update they can continue to use the Wireless Link with the MRx. If the issue occurs the Wireless Link should be removed from service and Philips Customer Care contacted. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |