China NMPA Product Recall - Mobile operating table

Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for products manufactured by MAQUET GmbH, has initiated a Class II voluntary recall of certain Mobile Operating Tables (Model 1131.12B0). This action, reported to the National Medical Products Administration (NMPA) on August 3, 2020, addresses a critical safety concern identified during post-market surveillance. The core issue involves poor welding in the operating table accessory adapter (Model 1002.6540) specifically manufactured between 2009 and 2013. This defect could lead to damage between the square hole and the first joint of the adapter, posing a risk of serious injury to patients during surgical procedures. While no personal injuries have been reported, the recall is a preventative measure to enhance medical device safety and uphold the standards of regulatory framework CFDA (Imported) No. 2013 2541619. In response, Maikewei (Shanghai) Medical Equipment Co., Ltd. is issuing a "Medical Device Recall Notice" to all affected customers and will replace all identified faulty adapters free of charge. This demonstrates the company's commitment to patient safety and compliance with regulatory guidelines.