Recall Z-2174-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
HeartSine Technologies Ltd
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
| Date | Jul 25, 2025 (initiated Jun 30, 2025) |
| Status | Open, Classified |
| Reason | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) |
| Root cause | Process change control |
| 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 i |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.