# FDA recall Z-2174-2025

> **HeartSine Technologies Ltd** · Class II · device recall initiated 2025-06-30.

## 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

- **Recall number:** Z-2174-2025
- **Recalling firm:** HeartSine Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-30
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belfast, United Kingdom

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2174-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2174-2025. Source: US FDA. Licensed CC0.

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