China NMPA Product Recall - Ventilator

On June 16, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for several models of its ventilators. This action, overseen by the National Medical Products Administration (NMPA) in China, addresses two significant safety concerns related to the polyester polyurethane (PE-PUR) sound-absorbing foam used within these devices. The primary issue involves the potential degradation of the PE-PUR foam into small particles, which could enter the device's air passage and subsequently be ingested or inhaled by users. Additionally, there is a risk that the foam may release certain organic compounds under specific operating conditions. Philips (China) has undertaken this recall to mitigate potential health hazards associated with these material defects in their products. The company advises consulting the "Medical Device Recall Event Report Form" for comprehensive details regarding affected product models, specifications, and batch information.