FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Physio-Control Recalls Defibrillator Over Concerns of Device Freezing

March 6, 2019

Physio-Control recalled its Lifepak15 monitor/defibrillator device, citing the risk of the device “locking up” after delivering an electric shock.

During a lock up, the device’s display monitor goes blank and the keypad becomes unresponsive, although the LED lights stay on and indicate the device has power.

The freezing prevents the device from giving defibrillation therapy until it is reset, putting patients at serious risk of injury or death. The Class I recall included more than 8,000 defibrillators.

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