Safety Information for EP-4 Computerised Cardiac Stimulator, St. Jude Medical
2009.04.20
Product group Medical electronics / Electromedical devices
Reference 00887/09
St. Jude Medical has issued a Field Safety Notice concerning a corrective action affecting the EP-4 Computerised Stimulator. If an internal fault condition were to occur and the power supply unit was connected to reversed polarity, over heating could occur, which may result in smoke or fire. In order to eliminate this risk a fuse modification is conducted for EP-4 Stimulator currently installed outside the USA and Canada.