# FDA recall Z-0862-2019

> **Physio-Control Inc** · Class I · device recall initiated 2019-02-01.

## Product

LIFEPAK 15 Monitor/Defibrillator    Product Usage:  The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

## Reason for recall

Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered.  This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0862-2019
- **Recalling firm:** Physio-Control Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-03-06
- **Termination date:** 2024-04-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0862-2019

## Citation

> AI Analytics. FDA recall Z-0862-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0862-2019. Source: US FDA. Licensed CC0.

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