Agency classClass IOur severity:Severe FDA (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.

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 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…
Manufacturer: Physio-Control Inc
Category: Medical Device — Cardiac Monitoring
Hazard: device-malfunction
electrical-failure
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 →

Same manufacturer · Physio-Control Inc

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