FDA-Device2017-03-15Class I
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.
Physio-Control, Inc.
Hazard
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Sold states
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, Ukraine, and Zambia.
Affected count
total 133,330 units (50,046 units in the US)
Manufactured in
11811 Willows Rd NE, N/A, Redmond, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2017Don't want to check this manually?
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