# FDA recall Z-1217-2023

> **HeartSine Technologies Ltd** · Class II · device recall initiated 2023-02-01.

## Product

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,  SAM 360P fully automatic defibrillator,  SAM 500P semi-automatic defibrillator with CPR Advisor

## Reason for recall

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

## Distribution

US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR  OUS: Australia, Czechia, Canada, New Zealand

## Key facts

- **Recall number:** Z-1217-2023
- **Recalling firm:** HeartSine Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-01
- **Report date:** 2023-03-15

- **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-1217-2023

## Citation

> AI Analytics. FDA recall Z-1217-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1217-2023. Source: US FDA. Licensed CC0.

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