FDA-Device2016-12-21Class II

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. Product Part Numbers V-15-2-000XXX

Physio-Control, Inc.
Hazard

Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.

Sold states
worldwide
Affected count
1399 units (866 in the US and 533 outside US)
Manufactured in
11811 Willows Rd NE, Redmond, WA, United States
Products
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. Product Part Numbers V-15-2-000XXX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2017

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