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U.S. Department of Health and Human Services

Class 2 Device Recall The LIFEPAK 15 monitor/defibrillator

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  Class 2 Device Recall The LIFEPAK 15 monitor/defibrillator see related information
Date Initiated by Firm March 11, 2010
Create Date December 14, 2016
Recall Status1 Terminated 3 on December 16, 2016
Recall Number Z-0761-2017
Recall Event ID 75743
510(K)Number K082937  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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
Code Information This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd NE
Redmond WA 98052-2003
For Additional Information Contact Rod J. Rylands
425-867-4261
Manufacturer 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.
FDA Determined
Cause 2		 Environmental control
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.
Quantity in Commerce 1399 units (866 in the US and 533 outside US)
Distribution worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL, INC.
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