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Terminated

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.

FDA Recall Z-0863-2019 · Posted 2019-02-26

Recalling FirmPhysio-Control Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2019-02-01
Date Terminated2024-04-18
Product Quantity682 kits

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

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

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