Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14847 |
| Brand Name: | Philips Heartstart MRx Monitor/Defibrillator |
| Model: | Models: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 |
| Affected: | Serial numbers within the range US00100100 to US00567299 |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems |
| Issue: | The Philips HeartStart MRx Monitor/Defibrillator can deliver a non- synchronised shock in the synchronised cardioversion mode. This can occur if the user rotates the Therapy Knob while simultaneously pressing the Sync button, then charges the MRx and presses the shock button. The MRx will still display R wave markers as if normally operating in synchronised cardioversion mode. The "Sync" Label will still be seen on the display. When the MRx is charged and the shock button pressed, the shock will be immediately delivered and may not be synchronised to the R wave. In addition, the label affixed to the top of the MRx device is not consistent with the MRx Instructions for Use on synchronised cardioversion. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/6/2013 |
