Safety Notice for Biphasic LIFEPAK® 12 Defibrillator/Monitors series, Physio-Control
2009.05.12
Product group Medical electronics / Electromedical devices
Reference 01248/09
Physio-Control Inc., a devision of Medtronic Inc., has issued an information concerning a recall to specific Biphasic LIFEPAK® 12 defibrillator/monitors manufactured with a printed circuit board assembly (PCBA) that contain a component with excess solder which could cause an intermittent short. If this occurs, it may result in no therapy delivery or delivery of an incorrect defibrillation waveform.