The Recall Desk
HighFDA (Devices)·Z-0863-2019·Announced 2019-03-06

Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

Physio-Control is recalling 682 LIFEPAK 15 Monitor/Defibrillator service kits because they may lock up after delivering a shock, leaving the monitor display blank.

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 high-risk medical device (defibrillator) with a functional defect that could prevent emergency care, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Physio-Control Inc is recalling 682 LIFEPAK 15 Monitor/Defibrillator service kits. The recall is due to reports that certain devices experience a lockup condition after a shock is delivered. This condition is defined as a blank monitor display with LED lights on, indicating power is on, but no response in the keypad or device functions.

The affected devices are distributed worldwide. The LIFEPAK 15 Monitor/Defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. It is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings.

Consumers and medical facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, it should be removed from service and the manufacturer contacted for instructions on repair or replacement.

The recalled product

Product
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/de
Manufacturer
Physio-Control Inc
Affected units
682

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 →