Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19357 |
| Brand Name: | Philips HeartStart MRx Defibrillator/Monitor |
| Model: | M3535A and M3536A |
| Affected: | |
| Software version: | F.03.06 and T.00.05 and earlier |
| 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: | MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off. If this occurs, the RFU indicator window displays a pattern that is not documented in the Instructions For Use or Service Manual. If this pattern appears and the device is turned on, it will revert the RFU back to an hourglass, indication that it is fully functional in all monitoring and therapy modes. There is no clinical risk if the device that has displayed this RFU pattern is turned on and put into service. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/11/2015 |
