BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2174-2025 · Initiated June 30, 2025

    Recall

    Recall Number
    Z-2174-2025
    Event Number
    96890
    Firm
    HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom
    FEI Number
    3004123209
    Product Code
    MKJ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    June 30, 2025
    Posted
    July 25, 2025

    Description

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

    Reason

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

    Action

    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: [email protected] 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 [email protected]

    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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Indonesia, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Singapore, South Korea, Taiwan, Thailand, and United Kingdom.

    Quantity

    190,516 units