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U.S. Department of Health and Human Services

Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator

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  Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator see related information
Date Initiated by Firm February 01, 2019
Date Posted February 26, 2019
Recall Status1 Open3, Classified
Recall Number Z-0863-2019
Recall Event ID 81939
510(K)Number K142430  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product LIFEPAK 15 Monitor/Defibrillator service kits

Product Usage:
The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Code Information Serial 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Recalling Firm/
Manufacturer
Physio-Control Inc
11811 Willows Rd Ne
Redmond WA 98052-2003
Manufacturer Reason
for Recall
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
FDA Determined
Cause 2
Software design
Action Stryker sent an Urgent Medical Device Safety Notice & Correction Action Required letter dated February 1, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers. ¿ Review the attached impacted device list. Go to www.strykeremergencycare.com/fa281response to provide Stryker verification of the status of the devices listed. ¿ Upon confirmation of your device status, a member of our field service personnel will contact you to arrange for the correction of your device. The devices subject to this field action are planned to be serviced by December 31, 2019. ¿ If you have questions regarding this matter contact Customer Support team by calling 1 800 442 1142 and selecting option 7.
Quantity in Commerce 682 kits
Distribution Worldwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL, INC.
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