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
This recall has been terminated (originally issued March 11, 2010).
- Company
- Physio Control, Inc.
- Recall Initiated
- March 11, 2010
- Terminated
- December 16, 2016
- Recall Number
- Z-0761-2017
- Quantity
- 1399 units (866 in the US and 533 outside US)
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
worldwide
Lot / Code Info
This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
Root Cause
Environmental control
Action Taken
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.