China NMPA Product Recall - Ventilator

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of its V60 ventilators, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on November 19, 2020. The recall stems from two identified potential problems with the ventilator's backup battery. Firstly, if the battery undergoes over-discharge, the device may activate a battery malfunction alarm, potentially affecting operational continuity. Secondly, extended storage of the ventilator without being connected to an AC power source could lead to the battery becoming unchargeable, rendering the backup power supply ineffective when needed. Importantly, Philips has confirmed that no adverse events related to these battery malfunctions have been reported to date. This proactive measure ensures compliance with medical device regulations by addressing potential product deficiencies to safeguard patient care. Detailed information regarding specific product models, specifications, and batch numbers involved in this recall is available in the accompanying "Medical Device Recall Event Report Form".