China NMPA Product Recall - Magnetic Resonance Imaging System

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Discovery MR750w 3.0T Magnetic Resonance Imaging Systems. This action, reported to the National Medical Products Administration (NMPA) on June 8, 2016, and publicly announced on August 29, 2016, addresses a patient safety concern. The company identified that under specific scanning conditions, a small area on the magnet's inner wall can generate elevated temperatures. This poses a thermal injury risk to patients who directly contact the magnet or do not use appropriate padding. The issue primarily occurs during frequent peri-central scanning of large-weight patients, such as off-central shoulder joint examinations, especially when the radiofrequency transmit gain is near its maximum setting. Affected products were distributed globally, including in the USA, Australia, Canada, and China. As corrective measures, GE Healthcare committed to notifying customers via letter, providing guidance on safe operation, and dispatching engineers to conduct free, on-site repairs for all identified affected systems.