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HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibr
Recalled August 6, 2025 · FDA recall Z-2174-2025 · HeartSine Technologies
Hazard
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) · FDA Class II
Units
190,516 units
Sold at
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.
Description
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Product
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Manufacturer(s)
HeartSine Technologies Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →