Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Recalled by Physio-Control Inc Due to Certain LIFEPAK 15 Monitors/ Defibrillators were reported to...

Date: February 1, 2019
Company: Physio-Control Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Physio-Control Inc directly.

Affected Products

LIFEPAK 15 Monitor/Defibrillator service kits 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.

Quantity: 682 kits

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide Distribution

About Physio-Control Inc

Physio-Control Inc has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report