China NMPA Product Recall - Monitor defibrillator

Philips (China) Investment Co., Ltd., in collaboration with its manufacturer Philips Medical Systems, announced an expanded recall of its Monitored Defibrillator models M3535A and M3536A on January 27, 2015. This action, overseen by the National Medical Products Administration (NMPA), added 31 devices to the existing recall scope in China, bringing the total affected units to 3751 globally.The recall addresses critical performance issues. Firstly, the MRx defibrillator is susceptible to electrical interference (Electrical Fast Transient Bursts) when connected to power or LAN, potentially leading to treatment delays or unintended shock delivery. Secondly, the device exhibited unintended behavior under specific non-standard clinical procedures not outlined in its Instructions for Use. This included accidental shock delivery if only one external defibrillator handpiece button was pressed under certain conditions, and device restart when transitioning modes with active data transfer and the 'Synchronize' button pressed. Lastly, the MRx might fail to perform on-demand pacing due to ECG lead dislodgement when skin resistance falls outside the design range, particularly on devices with specific software versions.To resolve these issues, Philips is providing a free software upgrade for all affected devices. Company representatives will directly contact users to facilitate the installation of this essential corrective measure, ensuring device safety and reliability.