# FDA recall Z-1272-2020

> **Philips North America LLC** · Class II · device recall initiated 2019-09-10.

## Product

Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063

## Reason for recall

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

## Distribution

HeartStart FRx:  US - CA, CT, FL, IL, MO, NY,TN, TX and WI  OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan.    HeartStart HS1:  US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI  OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan

## Key facts

- **Recall number:** Z-1272-2020
- **Recalling firm:** Philips North America LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2020-02-26
- **Termination date:** 2024-04-29

- **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-1272-2020

## Citation

> AI Analytics. FDA recall Z-1272-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1272-2020. Source: US FDA. Licensed CC0.

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