Recall Z-0862-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator 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
| Date | Feb 26, 2019 (initiated Feb 1, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root 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 plan |
| Quantity | 13,005 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc., Dec 19, 2014 |