Recall Z-0761-2017 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
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
| Date | Mar 11, 2010 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 1399 units (866 in the US and 533 outside US) |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc., Mar 11, 2009 |