PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: March 15, 2017 Initiated: January 13, 2017 #Z-1257-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Physio-Control, Inc.
Units Affected
total 133,330 units (50,046 units in the US)
Distribution
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.
Location
Redmond, WA

Frequently Asked Questions

What product 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.. Recalled by Physio-Control, Inc.. Units affected: total 133,330 units (50,046 units in the US).
Why was this product recalled?
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 15, 2017. Severity: Critical. Recall number: Z-1257-2017.