Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: February 01, 2019
Date Posted: February 26, 2019
Recall Status: Open, 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 Numbers: 45902644 46103169 45987054 45953396 45483757 45477666 43251338 43251330 43251337 43251331 43251332 43258935 43258939 43258937 43228302 43228304 43228306 43232897 43233020 43232896 43232894 43247620 42916265 42806505 42798882 42798883 42798884 42792295 42798879 42792292 42792293 42792290 42769668 42769682 42769669 42769683 42769623 42769622 42769667 42682340 42682365 41927593 41927587 41927584 41927586 41927588 41927590 41917524 41909860 41909864 41909859 41917523 41909862 41917526 41909861 41909863 41704060 41675566 41675569 41675568 41675572 41675581 41675579 41664085 41664089 41659957 41280566 41280565 41271940 47605976 47605977 47605978 47605975 47452142 47154005 47153982 47154010 46713840 46713846 46650660 46549016 46549030 46383960 46185756 46185751 45709172 45274780 45084606 44910255 44898379 44825194 44825193 44778785 44778791 44778818 44778776 44534650 44483720 44186841 43817113 43817111 43562342 43562343 43562345 43562346 43294428 42977696 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Recalling Firm/Manufacturer: Physio-Control Inc
11811 Willows Rd Ne Redmond WA 98052-2003
Manufacturer Reason: for RecallCertain 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: 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
Original source can be found here.
