The Recall Desk
HighFDA (Devices)·Z-0761-2017·Announced 2016-12-21

Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss

Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (defibrillator) with a functional defect (unexpected power loss) that could impact emergency care, but no injuries or illnesses have been reported.

Plain-English summary

Physio-Control, Inc. is recalling 1,399 units of the LIFEPAK 15 monitor/defibrillator. The recall involves 866 units in the United States and 533 units outside the United States. The devices are intended for use by trained medical personnel in emergency care settings.

The recall was initiated due to a customer complaint regarding a device that powered on and then powered down unexpectedly after a short period of use. The issue occurred when the device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. Power could be immediately restored by activating the power button after the device powered down.

The corrective action for this issue was completed by Velocitor Solutions in December 2010. Velocitor Solutions notified their customers of this action in 2010. The consignee list was not provided to Physio-Control.

The recalled product

Product
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

Distribution

Distribution scope not specified by the agency.