Field Safety Notice concerning BeneHeart D6 defibrillator / monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
2010.09.30
Product group Medical electronics / Electromedical devices
Reference 03470/10
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has issued a Field Safety Notice concerning a corrective action of the BeneHeart D6 defibrillator / monitor. A high voltage (HV) printed circuit board assembly (PCBA) may contain a component with excess solder which might create a short. There is the risk that affected devices do not deliver therapy. In Germany, the product is not in the market.