Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13185 |
| Brand Name: | Philips MRx HeartStart Defibrillator |
| Model: | models M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6. |
| Affected: | All units manufactured prior to June 2012 |
| 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: | When HeartStart MRx Defibrillator Monitors are used in external transport and EMS environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads CPR therapy cable and external paddles cable) and the MRx therapy connection port may experience higher than expected levels of stress causing accelerated wear. Without routine periodic inspections and preventive action by users, wear of the connection could ultimately prevent the device from sensing that the pads/paddles therapy cable is connected. This wear also may cause the MRx to inappropriately identify the pads therapy cable, external paddles, or internal paddles. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/7/2012 |
