Product Notice – Urgent Recall
HeartSine Samaritan Public Access Defibrillators (PAD) 350P, 360P, 500P
24 June, 2025
TGA Recall Reference: RC-2025-RN-00505-1
Download: Recall Notice
Why is this product being recalled?
Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators.
A manufacturing problem related to a circuit board component may impair the device’s ability to function or cause failure. This failure could occur at any point when the device is holding a charge. This may be in preparation to deliver therapy, while delivering a shock, or after shock delivery.
The device becomes inoperable after the failure occurs.
The problem was observed during quality testing and not during patient use.
What are the risks?
If this issue occurs, the device may fail to deliver intended therapy during use, potentially leading to a delay in treatment or no treatment being delivered during use.
- No shock delivery
- Delay in treatment
Affected Devices
| ARTG number | Catalogue number / Product model |
| 156690, 228210 | 350BASUK10 HeartSine SAM 350P |
| 360BASUK10 360BASUKGW HeartSine SAM 360P | |
| 500BASUK10 HeartSine SAM 500P |
| Affected serial numbers |
| A subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H. Please check if your AED serial number is affected as detailed below. To view the list of all serial numbers included in this recall, please visit the Stryker website - external site. |
ARTG number
Catalogue
number
Product
Model
Affected serial
numbers
156690, 228210
350BASUK10
HeartSine SAM 350P
360BASUK10
360BASUKGW
HeartSine SAM 360P
500BASUK10
HeartSine SAM 500P
A subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H. Please check if your AED serial number is affected as detailed below.
To view the list of all serial numbers included in this recall, please visit the Stryker website - external site.
What should I do?
- Contact Styker via email on heartsine.recall@stryker.com or call on 02 9170 9131. You can also notify Stryker via an online form - external site.
- Once your response is received, Stryker will contact you to organise a replacement device.
- In the meantime, Stryker recommends keeping your HeartSine Samaritan PAD in service until a replacement device is available.
Further Information
Please contact Stryker on 02 9170 9131 or email heartsine.recall@stryker.com for further information.
For more information on safety alerts and product notices, please visit the Therapeutic Goods Administration (TGA) alerts resource page.