Product Notice – Safety Alert
ZOLL® Powerheart G5 AED Devices
11 April, 2025
Product Details: ZOLL® Powerheart G5 AED Devices
TGA Recall Reference: RC-2025-RN-00298-1
Issue Summary
The device manufacturer, ZOLL® Medical Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a Product Alert. ZOLL has identified some devices may display Error Code EC 501 during self-tests. This error may affect the device’s ability to deliver lifesaving therapy. The issue is believed to result from exposure to humidity outside the recommended storage conditions.
Affected Devices (Supplied by St John NSW)
ARTG number
352596, 213065
Device name
ZOLL® Powerheart G5 AED (Semi-Automatic and Fully Automatic)
Product Model
Fully Automatic AED
Semi-Automatic AED
Affected serial numbers
CSG5CPR-Pack
Fully-Auto AED with CPR Feedback
CSG5-Pack
Fully-Auto AED
CSG5SCPR-Pack
Semi-Auto AED with CPR Feedback
CSG5S-Pack
Semi-Auto AED
Actions Required
- Review the three documents linked below:
- Monitor the device (AED) regularly for self-test results and any warnings.
- Ensure the device is stored between 0°C to 50°C and 10% to 95% humidity (non-condensing).
- If EC 501 appears: Contact ZOLL® Medical Australia directly for inspection and replacement on 1800 605 555 or email: serviceanz@zoll.com
Important
- All technical troubleshooting and replacement will be managed directly by ZOLL.
- St John NSW remains available to assist with any enquiries on 1300 785 636
We appreciate your urgent attention to this matter. Maintaining your AED’s readiness is critical to saving lives.
For more information on safety alerts and product notices, please visit the Therapeutic Goods Administration (TGA) alerts resource page.