HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Reported: August 6, 2025 Initiated: June 30, 2025 #Z-2174-2025
Product Description
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Reason for Recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Details
- Recalling Firm
- HeartSine Technologies Ltd
- Units 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, 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.
- Location
- Belfast
Frequently Asked Questions
What product was recalled? ▼
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator). Recalled by HeartSine Technologies Ltd. Units affected: 190,516 units.
Why was this product recalled? ▼
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2174-2025.
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