Recall Z-2174-2025
HeartSine Technologies Ltd · initiated June 30, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
Codes / lots: U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23…
Reason for recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FDA-determined cause: Process change control
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
Details
- Recall number
- Z-2174-2025
- Initiated
- June 30, 2025
- Posted by FDA
- July 25, 2025
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 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, 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…
- Recalling firm
- HeartSine Technologies Ltd, Belfast