China NMPA Product Recall - Ventilator

Maquet Critical Care AB has initiated a voluntary Class II recall of certain ventilators and related products, reported by Maquet (Shanghai) Medical Equipment Co., Ltd. The primary issue identified is a failure to verify the safety of the ventilators when used in neonatal mode with a third-party active humidifier during pre-use testing, even in the absence of leaks. This critical safety concern prompted the company's action. The recall, overseen by the National Medical Products Administration (NMPA), involves specific ventilator models, including those with National Food and Drug Administration Import Medical Device Registration Numbers 20143543624 and 20143543625, as well as National Medical Device Registration Certificates 20193082109 and 20193082113. It is important to note that the products subject to this recall were not imported into China. The required action by Maquet Critical Care AB is to conduct this voluntary recall to address the identified safety deficiency and prevent potential risks associated with the unverified use of these devices.