Physio-Control, Inc. recalls LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes soft…

Recall date

January 27, 2016

Source

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

Recall number

Z-1993-2016

FDA classification

Class II

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile,…

Why it was recalled

The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.

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

What was recalled

LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.