Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13427 |
| Brand Name: | Philips Heartstart MRx Monitor/Defib |
| Model: | M3535A, M3536A, M3536M4, M3536M5, M3536M6 |
| Affected: | Multiple |
| Software version: | |
| Recalling Organisation: | Laerdal (New Zealand) Ltd 79 Apollo Drive Rosedale Auckland 0632 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems |
| Issue: | Certain HeartStart MRx monitor/defibrillators were manufactured with compromised components within the time frames of July 12, 2011 through September 2, 2011 and January 19, 2012 through May 22, 2012. May present the folowing behaviours: A. In AED mode the MRx experiences difficulty interpreting pads ECG waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to anlyze the waveform. B. in Manual mode the user may have trouble interpreting the pads ECG waveform and determining whether or not to deliver therapy. In addition the MRx may provide erroneous alarms or indicate an asystolic rhythm when paddles are not in patient cntact. C. If CPR meter is in use, users may not get an accurate impedance derived ventilation feedback. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/8/2012 |
