# FDA recall Z-2143-2023

> **HeartSine Technologies Ltd** · Class II · device recall initiated 2023-04-26.

## Product

HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

## Reason for recall

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

## Distribution

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN,	MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA,	VT,	WA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy,	Japan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.

## Key facts

- **Recall number:** Z-2143-2023
- **Recalling firm:** HeartSine Technologies Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-26
- **Report date:** 2023-07-19

- **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-2143-2023

## Citation

> AI Analytics. FDA recall Z-2143-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2143-2023. Source: US FDA. Licensed CC0.

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