Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23802 |
| Brand Name: | External Defibrillator (AED) |
| Model: | M3538A Lithium-Ion Batteries |
| Affected: | |
| 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 manufacturer discovered that certain M3538A Lithium-Ion Batteries manufactured between January 19th, 2018 and March 20th, 2018 for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power due to an internal component failure. Update 23 November 2018: The FDA has made some changes to the initial recall letter regarding FSN86100195 MRx Battery. Action to be taken be customer o Initial Letter States: Should a battery fail to charge, or if the LED status indicator stops functioning, the battery should be removed from service. If the battery exhibits none of these symptoms, it can be used until a replacement is obtained. o Updated Letter States: If any affected batteries are found, remove them from service immediately. |
| Recall action type: | Correction |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/11/2018 |
