China NMPA Product Recall - Magnetic Resonance Imaging System

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its Magnetic Resonance Imaging (MRI) System on January 17, 2020. The company identified an issue where certain MR systems might incorrectly set dates, potentially leading to inaccurate date information being recorded on medical images. This recall was reported to the National Medical Products Administration (NMPA) in China. The company's proactive measure addresses a potential data integrity concern, ensuring the reliability of date stamps on diagnostic images. The specific models, specifications, and batch numbers affected are detailed in the accompanying Medical Device Recall Event Report Form, which prompted the public notification by the Shanghai Municipal Drug Administration.