Medical device recalls Moderate risk

Physio-Control, Inc. recalls The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency c…

Recall date
March 11, 2010
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0761-2017
FDA classification
Class II
Brand / firm
Physio-Control, Inc.
Sold / distributed
worldwide

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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