Home / Recalls / Medical Devices
Physio-Control, Inc. recalls The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency c
Recalled December 21, 2016 · FDA recall Z-0761-2017 · Physio-Control
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. · FDA Class II
Units
1399 units (866 in the US and 533 outside US)
Sold at
worldwide
Description
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.
Product
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
Manufacturer(s)
Physio-Control, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →