LIFEPAK 20e DEFIBRILLATOR/MONITOR recalled over injury risk

Recall date

December 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Physio-Control, Inc. recalls LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in…

Recall number

Z-0294-2018

FDA classification

Class I

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide Distribution

Why it was recalled

Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.