The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor...
FDA Recall #Z-0761-2017 — Class II — March 11, 2010
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.
Recalling Firm
Physio-Control, Inc. — Redmond, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1399 units (866 in the US and 533 outside US)
Distribution
worldwide
Code Information
This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated