Physio-Control, Inc. recalls LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended f…

Recall date

January 12, 2017

Source

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

Recall number

Z-1123-2017

FDA classification

Class I

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany,…

Why it was recalled

The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).

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 15 Monitor, Automated External Defibrillator (AED), 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.