Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22713
Brand Name:HeartStart HS1 & FRx
Model:HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs
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 has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 AEDs that were manufactured between 2002-2013. Virtually all of these resistor-related failures were detected through the device's automatic self-testing, alerting the user by issuing audible chirps. The in-use reliability of these AEDs is greater than 99.9% when the AED determines a cardiac arrest victim is in need of shock therapy.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/3/2018
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