| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00136-1 |
| Product Name/Description |
HeartStart MRx and FR3
HeartStart FR3
Model Number 861388 and 861389
Q-CPR Model Number 989803149941
ARTG: 280486
HeartStart MRx
Model Number M3535A and M3536A
Q-CPR Model Numbers: 453564145481, 453564257691, 989803162401 and M4761A
ARTG: 95661 and 261352 (both restricted to no longer include this product)
Q-CPR Meter
ARTG: 213197 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips is sending formal notice of a Medical Device Labeling Correction to ensure the following:
-HeartStart MRx customers have access to the HeartStart MRx Addendum as a supplement to the MRx Instructions for Use (IFU)
-HeartStart FR3 customers whose Q-CPR Meters are used on an MRx are aware that certain information contained in the FR3 AED Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) also applies to use of the Q-CP Meters with the MRx. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
In August 2015, Philips distributed a Q-CPR Addendum to the MRx Instructions for Use (IFU). This information was already available in the HeartStart FR3 Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) - this was undertaken under RC-2015-RN-00832-1.
Philips is requesting MRx users ensure that their copy of the MRx IFU contains the Addendum.
For FR3 customers, ensure that the IFU for any MRx with which your Q-CPR Meter may be used contains the Addendum
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 251 400 - Customer Care Centre |