Physio-Control Class 1 Recall of LifePak 15 Defibrillator

Physio-Control has begun a Class 1 recall of its LifePak 15 monitor/defibrillator because the device may “lockup” (freeze) after a shock is delivered. “When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device although the device’s LED lights remain on and indicates the device still has power,” a recall notice says. Once the device freezes, it cannot provide defibrillation therapy until the device is reset by restarting it or removing and reinserting all connected power sources, it says. A delay in delivering a shock could and has resulted in serious patient injury including death.

Earlier this month, Physio-Control sent customers an “Urgent Medical Device Safety Notice & Correction” letter. The letter told customers that the company will provide a firmware update for affected devices to resolve the issue.