# FDA recall Z-0175-2019

> **Philips Electronics North America Corp.** · Class II · device recall initiated 2018-10-10.

## Product

Philips HeartStart FR3 Defibrillator, Model: 861388, 861389    Product Usage:  The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

## Reason for recall

Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

## Distribution

Worldwide Distribution - U.S Nationwide in the states of:  GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE;    Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom

## Key facts

- **Recall number:** Z-0175-2019
- **Recalling firm:** Philips Electronics North America Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-10
- **Report date:** 2018-10-24
- **Termination date:** 2022-08-19

- **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-0175-2019

## Citation

> AI Analytics. FDA recall Z-0175-2019. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0175-2019. Source: US FDA. Licensed CC0.

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