| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00344-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5 & M3536M6
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either Manual Defib or AED mode. If this occurs, the MRx may simultaneously display a "No Shock Delivered" message along with a "Shock Equip Malfunction" INOP and a Red X in the RFU indicator. In addition, the pads ECG waveform may display a non-physiologic flat line rhythm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing a software update to correct the issue. In the interim, Philips is providing users with work around instructions and recommends that a backup defibrillator be made available during use. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |