Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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…
Manufacturer: Physio-Control Inc
Category: Medical Device — Cardiac Monitor/Defibrillator
Hazard: device-lockup
monitor-failure
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 manufacturer · Physio-Control Inc

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Same hazard · device lockup