FDA recall Z-2174-2025

Product

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)

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.

Key facts

Status

Ongoing

Initiation date

2025-06-30

Report date

2025-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belfast, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2174-2025