Physio-Control, Inc. recalls LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as…

Recall date

January 16, 2017

Source

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

Recall number

Z-1143-2017

FDA classification

Class II

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA,…

Why it was recalled

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)