# FDA recall Z-1820-2024

> **HeartSine Technologies Ltd** · Class II · device recall initiated 2024-04-08.

## Product

HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

## Reason for recall

Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.

## Distribution

US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-1820-2024
- **Recalling firm:** HeartSine Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-08
- **Report date:** 2024-05-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2024

## Citation

> AI Analytics. FDA recall Z-1820-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1820-2024. Source: US FDA. Licensed CC0.

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