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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

FDA Recall Z-0761-2017 · Posted None

Recalling FirmPhysio-Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2010-03-11
Date Terminated2016-12-16
Product Quantity1399 units (866 in the US and 533 outside US)

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.

Firm Action

Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.

Root Cause

Environmental control

Distribution Pattern

worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082937LIFEPAK 15 MONITOR/DEFIBRILLATORPhysio-Control, Inc. · 2009-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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