HeartSine Product Defect Correction | May 2024

Urgent Product Defect Correction

TGA Reference #: RC-2024-RN-00356-1

ARTG #: 156690 – SAM 350P and SAM 500P
228210 – SAM 360P

Product Field Action #: RA 3540155

Please be advised that Stryker has initiated an Urgent Product Defect Correction for HeartSine® samaritan® Public Access Defibrillators.

Affected Product: HeartSine® samaritan Public Access Defibrillators.

Affected Product Code: 350P, 360P, 500P

What is the issue?

 A manufacturing related issue may impair device audio prompts. Stryker is issuing a customer notification to remind customers to follow the User Manual and power the device upon receipt to ensure the audio prompts function as intended.

Prior to dispatch, the team at First Aid Accident & Emergency power on your device and check for audio prompts. Stryker have issued an additional maintenance supplement to be actioned every three months – You are required to turn the Defibrillator on once every 3 months to check the audio prompts function works as intended. Please keep a copy of the HeartSine Maintenance Supplement with the User Manual and perform the checks listed in the Maintenance Supplment once every three months. 

Instructions: how to check your defibrillator

As part of the monthly maintenance check, we recommend that you perform the following check once every three months. This can be done quickly, without removing the AED from its case.

  1. Press the On/Off button to turn on the AED..
  2. Listen for, but do not follow, the voice prompts to ensure you can hear the prompts.
  3. If you do not hear a prompt, contact your authorised distributor or HeartSine Technologies directly.
  4. If you hear the prompt “Adult patient” and/or “Call for medical assistance,” no further action is needed.
  5. Press the On/Off button again to turn off the AED and verify that the status indicator is flashing green.

If you hear a warning message or see a red flashing status indicator, consult on of our team at First Aid Accident & Emergency on 0755205068 or check the troubleshooting guide in the device user manual/user handbook.


Devices affected by this notification date back to 2016 and begin with the following prefixes and device codes: 16B, 16C, 16D, 16E, 16G, 16H 17B, 17D, 17E, 17G, 17H 18B, 18D, 18E, 18G, 18H 19B, 19D, 19E, 19G, 19H 20B, 20D, 20E, 20G, 20H 21B, 21D, 21E, 21G, 21H 22B, 22D, 22E, 22G, 22H 23B, 23D, 23E, 23G, 23H 24B, 24D, 24E, 24G, 24H.
Please check your devices, if devices with the specified serial number prefixes are found, please follow these instructions to power cycle your device.

  1. Review the notification letter and locate your affected devices.
  2. Complete the ‘Power Cycle Instructions’ (above) by turning on your device.
  3. Keep a copy of the Maintenance Supplement with the User Manual, and perform the checks listed in the Maintenance Supplement once every three months.
  4. Please complete and submit the Acknowledgement Form.



please complete the acknowledgement form now