China NMPA Product Recall - Monitor defibrillator

Philips (China) Investment Co., Ltd. has initiated an expanded recall for its Monitored Defibrillator (MRx) devices, as publicly reported by the National Medical Products Administration (NMPA) on January 27, 2015, based on Philips’ internal report dated January 6, 2015. The recall scope in China has been broadened to include an additional 16 units, bringing the total to 47 affected devices globally and within China. The primary issues necessitating this recall involve two critical product deficiencies affecting the MRx devices. Firstly, the CO2 inlet for the end-expiratory carbon dioxide (EtCO2) monitoring device may be susceptible to being pushed into the MRx housing, making it inaccessible if users attempt to force it rather than rotating it clockwise as per the instructions. Secondly, the device's handle may detach from the MRx housing due to damage to the upper base of the rear cover. In response to these significant product concerns and under the NMPA's regulatory guidance, Philips is implementing corrective actions. The company will provide a complimentary hardware upgrade for all identified affected devices. Philips representatives are actively contacting users of the affected units to arrange for the scheduling and installation of these essential hardware upgrades.