# FDA recall Z-3120-2026

> **HeartSine Technologies Ltd** · Class II · device recall initiated 2026-07-27.

## Product

HeartSine SAM 350P  350P US Device, US English - 2 Min CPR  UDI-DI codes:  0506016712067    350P US Device, US English (American Airlines) - 2 Min CPR  UDI-DI code:  0506016712207    350P US Device, US English with Gateway - 2 Min CPR  UDI-DI code:  0506016712804    HeartSine SAM 360P  360P US Device, US English - 2 Min CPR  UDI-DI code:  0506016712068    HeartSine SAM 450P  SAM 450P   US Device, US English (2 min CPR)  UDI-DI code:  0506016712069    The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs:  " Unconscious  " Not breathing  " Without circulation (without a pulse)  The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).

## Reason for recall

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.

## Key facts

- **Recall number:** Z-3120-2026
- **Recalling firm:** HeartSine Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-27
- **Report date:** 2026-09-16

- **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-3120-2026

## Citation

> MORVS. FDA recall Z-3120-2026. Retrieved 2026-10-25 from https://api.morvs.ai/recall/Z-3120-2026. Source: US FDA. Licensed CC0.

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