PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 21, 2016 Initiated: March 11, 2010 #Z-0761-2017

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Physio-Control, Inc.
Units Affected
1399 units (866 in the US and 533 outside US)
Distribution
worldwide
Location
Redmond, WA

Frequently Asked Questions

What product was recalled?
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. Recalled by Physio-Control, Inc.. Units affected: 1399 units (866 in the US and 533 outside US).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0761-2017.