The Recall Desk
HighFDA (Devices)·Z-0862-2019·Announced 2019-03-06

Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition

Physio-Control is recalling 13,005 LIFEPAK 15 Monitor/Defibrillators because they may lock up after delivering a shock, leaving the display blank and unresponsive.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a critical medical device used in emergency cardiac care that may fail to function after a shock. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or deaths are mentioned in the source text.

Plain-English summary

Physio-Control Inc. is recalling 13,005 units of the LIFEPAK 15 Monitor/Defibrillator. The device is a complete acute cardiac care response system designed for basic and advanced life support patient management protocols. The units were distributed worldwide.

The recall is due to a reported lockup condition that can occur after a shock is delivered. In this condition, the monitor display goes blank while the LED lights remain on, indicating the device has power. However, the keypad and device functions do not respond.

The source text does not specify a remediation action for consumers or medical personnel. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

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 i
Manufacturer
Physio-Control Inc
Affected units
13,005

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Physio-Control Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same hazard · device lockup

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