China NMPA Product Recall - Ventilator, non-invasive ventilator

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall initiated by Respironics, Inc., reported by Philips (China) Investment Co., Ltd. This recall affects specific models of non-invasive ventilators (National Medical Device Registration Certificate 20163545170) and ventilators (National Medical Device Registration Certificate 20192082053, 20152541271). The recall, published on April 25, 2024, under NMPA Index No. JGXX-2024-10074, addresses detected internal errors within the equipment. These errors could potentially trigger alarms, leading to treatment interruptions for patients. A Class I recall indicates a high probability of serious adverse health consequences or death. The document does not specify inspection dates, as this is a company-initiated recall. Further details, including affected batch numbers and specifications, are provided in the attached "Medical Device Recall Event Report Form." All entities using these devices are urged to consult the complete recall documentation for precise guidance and product identification.