| TGA Action ID |
RC-2025-RN-00298-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ZOLL Powerheart G5 AED Semi-Automatic and Fully Automatic AED
Multiple item numbers and serial numbers
ARTG's: 352593 & 213065 |
| ARTG Number |
213065, 352593 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The G5 AED automatically performs self-tests to alert users of conditions that may interfere with its ability to delivery lifesaving therapy. Error Code EC 501 is a specific error code that is generated during the device’s automated self-test, if displayed, cannot delivery lifesaving therapy.
There is a potential risk for patient harm from a device unable to deliver lifesaving therapy if users do not notice EC 504 or other device alerts before attempted device use.
The failure mode (EC501) is likely due to exposure of humidity outside the device’s published specifications.
Investigations are ongoing.
ZOLL is communicating the importance of storing the at-risk devices in areas with appropriate humidity. |
| Instructions for Customers/Users |
Customers are to:
- Ensure the device is stored at the published specifications
- Monitor device for self-tests results and take actions to resolve any alerts.
This action has been closed out on 03/12/2025 |
| Action Commencement Date |
10/04/2025 |
| Responsible Entity |
|
| Contact Information |
intlservice@zoll.com - Technical support team |