HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)

FDA device recall Z-2174-2025 · posted 2025-07-25 · Open, Classified

Recall details

Recalling firm

HeartSine Technologies Ltd

Reason for recall

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Action taken

On 06/30/2025, the firm sent via USPS First Class an "URGENT: MEDICAL device recall" Letter to customers informing them Stryker has determined that for the HeartSine samaritan PAD, 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. Customer are instructed to: 1. Identify impacted devices by verifying if their device serial numbers are included in the list at the link https://www.stryker.com/us/en/emergency-care/product-notice/heartsine/index.html 2. Submit customer response electronically via the QR code scan or link https://bit.ly/fa318-heartsine, or response via email to: RSRecall@stryker.com and include the following Subject: FA 318 HeartSine T3 - Response from <<>> Email Body: -Customer ID, Customer Name, title and email address -The number of devices impacted by model, and serial numbers -Provide if any devices have been further distributed 3. Until a replacement is available, Stryker recommends keeping HeartSine device in service if there is no alternative public access defibrillator. For questions or concerns, contact Stryker Customer at +1 800-787-9537, option 2 from 8:00 AM to 7:00 PM (Eastern Time) Monday thru Friday or contact Technical Support at heartsinesupport@stryker.com

Root cause

Process change control

Status

Open, Classified

Product code

MKJ

Quantity affected

190,516 units

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM,

Date initiated

2025-06-30

Date posted

2025-07-25

Location

Belfast, United Kingdom