China NMPA Product Recall - Electric transfer machine

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Arjo Huntleigh AB for its electric transfer machines. This recall, published on March 11, 2021, addresses a critical safety concern where the boom and weighing device bottom disconnect from the main unit in specific models and batches. The affected products, registered under National Medical Device Registration No. 20160112, were distributed by Hou Jieyou (Suzhou) Medical Equipment Trading Co., Ltd. The identified defect poses a potential risk to patient and user safety during operation, necessitating immediate corrective action. Arjo Huntleigh AB proactively initiated this voluntary recall to ensure compliance with regulatory standards and maintain product integrity. All customers with the affected electric transfer machines are advised to refer to the "Medical Device Recall Event Report Form" for detailed information regarding specific models, specifications, and batch numbers. The company is responsible for implementing the necessary steps to retrieve or rectify the non-conforming devices, mitigating any potential hazards associated with the identified issue. This action underscores the manufacturer's commitment to patient safety and adherence to NMPA's medical device regulations.