China NMPA Product Recall - Ventilator

Respironics California, LLC, in collaboration with Philips (China) Investment Co., Ltd., has initiated a voluntary Class III recall for certain ventilator models. This significant action, reported to the National Medical Products Administration (NMPA) on October 7, 2023, addresses a critical product safety concern impacting devices registered under National Medical Device Registration Certificate 20163085139. The primary issue stems from potential resistor damage within the power management board of specific ventilator batches. This defect can lead to unexpected power failures and trigger alarms, posing a potential risk to patient safety. While not an inspection, the recall serves as a proactive measure to mitigate these risks. Under the regulatory oversight of the NMPA, this voluntary recall requires Respironics California, LLC to remove the compromised devices from the market. Further specifics regarding the exact affected models, specifications, and batch numbers are detailed in the attached "Medical Device Recall Event Report Form," which guides the effective implementation of this critical safety action.