Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22606
Brand Name:HeartStart FR3
Model:861388 and 861389
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
Brand Name:HeartStart MRx External Defibrillator (AED)
Model:M3535A and M3536A
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
Brand Name:Q-CPR Meter
Model:
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:Laerdal Medical AS
Issue:The manufacturer is advising all customer
1. To ensure HeartStart MRx customers have access to the HeartStart MRx Addendum as a supplement to the MRx Instructions for Use (IFU)
2. To ensure HeartStart FR3 customers whose Q-CPR Meters are used on an MRx are aware that certain information contained in the FR3 AED Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) also applies to use of the Q-CP Meters with the MRx.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/2/2018
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