# FDA recall Z-0080-2022

> **Philips North America LLC** · Class II · device recall initiated 2021-02-09.

## Product

Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

## Reason for recall

Customers were not notified of previous recalls associated with various defibrillator models.

## Distribution

U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA.  International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.

## Key facts

- **Recall number:** Z-0080-2022
- **Recalling firm:** Philips North America LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-09
- **Report date:** 2021-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2022

## Citation

> AI Analytics. FDA recall Z-0080-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0080-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*