China NMPA Product Recall - Multifunctional remote-controlled X-ray diagnostic system; multi-purpose X-ray system

GE Medical Systems Trading Development (Shanghai) Co., Ltd., on behalf of its manufacturer, GE Medical Systems, initiated a voluntary recall of its multifunctional remote-controlled X-ray diagnostic systems and multipurpose X-ray systems. The recall, reported on June 15, 2015, and published by the National Medical Products Administration (NMPA) on July 13, 2015, addresses a potential risk of detachment from LCD monitor brackets. The affected models include Precision RXi and Precision MPi, which are utilized in medical institutions for radiography and fluoroscopy diagnoses. No personal injuries have been reported related to this issue. Notably, the recalled products were not sold in China; however, they were distributed in regions such as the United States, Canada, the European Economic Area, and Australia. The NMPA's regulatory framework in China prompted provincial, autonomous region, and municipal food and drug administrations to strengthen their supervision and management over similar products, despite the lack of affected units within the country.