Physio-Control, Inc. recalls The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and…

Recall date

January 13, 2017

Source

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

Recall number

Z-1257-2017

FDA classification

Class I

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia…

Why it was recalled

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

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

The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.