AED RECALLS
New HeartSine Recall
Effective June 2025
Products affected:
Affected devices include a subset of HeartSine samaritan PAD Models; 350P, 360P, 450P and 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.
Per Stryker's letter it has been determined during extensive quality testing that a manufacturing process issue 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 in preparation to deliver therapy, while delivering a shock, or after shock delivery. The device becomes inoperable after the failure occurs.
To see if your HeartSine AED is included in the recall please visit.
https://www.stryker.com/us/en/emergency-care/product-notices/heartsine/fa318-t3/be.html
Once you click the above link, scroll to the bottom of the page and you will see a window to enter your serial number.
AEDs included in the recall will show up yellow under the window.
AEDs not included in the recall will show an "N/A" under the window.
If you need assistance with determining if you AED has been affected by this recall please contact our office at 808-440-8988 or info@aed808.com.
HeartSine AEDs 350P, 360P, 450P
(Affected devices manufactured between 2016-2024)
HeartSine has issued a field corrective notification dated April 2024. The issue could prevent the HeartSine device from delivering instructional voice prompts to the user during use of the device. HeartSine Technologies recommends that the user carries out the check in described in the linked document (see below),
Step 6-Step 8, once every three (3) months.
This can be carried out quickly without removing the AED from its case.
Click on the link below the picture to see details of the Corrective Action and what serial numbers were affected. To see if your AED is affected find the serial number on the PAD-PAK as described in the picture below.
