China NMPA Product Recall - Anesthesia machine

MAQUET CRITICAL CARE AB, supported by MAQUET (Shanghai) Medical Equipment Co., Ltd., initiated a voluntary Class II recall of specific anesthesia machine models and batches, as announced by the National Medical Products Administration (NMPA) on January 31, 2023. The recall stems from a critical ventilation problem identified in the affected devices, which could compromise patient safety. This issue prompted the manufacturer to take swift corrective action under the NMPA's regulatory framework. The recall specifically impacts anesthesia machines registered under Certificate Nos.: 20163082966 and 20223080583. Although no specific inspection dates were provided in the document, the recall itself represents a regulatory response to a detected product deficiency. MAQUET CRITICAL CARE AB is addressing the ventilation issue, and further details, including affected models, specifications, and batch numbers, are available in the "Medical Device Recall List" and the "Medical Device Recall Event Report Form" for stakeholders and healthcare professionals.