China NMPA Product Recall - Guardian removal device

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its MRx monitored defibrillator products (models M3535A, M3536A) on December 12, 2014, as reported by the National Medical Products Administration (NMPA). The recall addresses several critical issues impacting device performance. Firstly, the MRx device could experience treatment delays or unexpected energy delivery when exposed to Electrical Fast Transient Bursts (EFTs) from power sources or LAN connections. Secondly, specific non-standard clinical workflows, not outlined in the Instruction for Use, could lead to unintended device behavior, including an accidental shock delivery or device restart. Lastly, issues with ECG electrode pad impedance measurement could cause ECG lead detachment, potentially leading the MRx to stop on-demand pacing, particularly on devices with software version B.06.XX. In response, Philips is providing a free software upgrade for all affected devices. Company representatives will contact users to facilitate the installation of this essential software update.