| TGA Action ID |
RC-2026-RN-00670-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HeartHero Elliot Automated External Defibrillator (AED)
Rapid Battery Depletion: All HeartHero Elliot AEDs are potentially affected
Green Power Button: Multiple serial numbers |
| ARTG Number |
387771 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
HeartHero has identified two problems which may impact the Elliot AED.
1) Rapid Battery Depletion
Elliot AEDs in Australia may experience unexpectedly rapid battery depletion after being placed into service. This occurs because the service provider has discontinued LTE-M network support in Australia. During periodic self-tests the device repeatedly attempts to connect to a network that is no longer available. After the connection attempt the device does not correctly return to its normal low-power state, resulting in accelerated battery drain. Devices that get stuck and that do not return to low-power Standby, can exhaust the battery in less than a week.
In some cases, the device may become non-functional without the usual low-battery warning being presented or not being presented in a timely manner. A non-functional AED may be unavailable to deliver defibrillation therapy in sudden cardiac arrest.
2) Green Power Button
Certain serial numbers of Elliot AEDs may have a green power button that is sticky or does not consistently make electrical contact. In these cases, pressing the green button may not wake the AED and may give the user the impression that the device is not functioning. If the green button does not work, a person trying to use the AED in an emergency may lose time or may think the device is not working. The Elliot AED can still be started by pulling the red handle.
To date, no patient harm has been reported. |
| Instructions for Customers/Users |
Rapid Battery Depletion
Customers are to:
- Place the device in Airplane Mode using the HeartHero mobile application, which stops cellular registration attempts and restores normal battery consumption.
- Confirm battery status and replace depleted batteries if needed.
HeartHero will release a firmware update returns the device to low-power Standby after a failed network registration attempt and defaults devices to Airplane Mode. Customers will be notified when the firmware update is available.
UPDATE 22/09/2026:
The firmware update is available. Follow the instructions in the Customer Letter to update devices to firmware version 2.4.4 via the HeartHero mobile application or HeartHero AED Portal. Following completion of the firmware update, confirm battery status and replace depleted batteries if needed.
Green Power Button
Customers are to:
- Check the serial number of their device against Appendix A of the Customer Letter.
- If required, complete the Green Power Button Check described in the Customer Letter.
- If this check fails, contact Elliot Australia to organise a replacement. Until the replacement device arrives, the AED can still be activated by pulling the red handle and used to provide therapy. |
| Action Commencement Date |
4/09/2026 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |