China NMPA Product Recall - Magnetic Resonance Imaging System

The National Medical Products Administration (NMPA) issued a document on September 27, 2017, detailing a Class II voluntary recall initiated by GE Medical Systems, LLC. The recall, reported internally on August 4, 2017, addresses various Magnetic Resonance Imaging (MRI) systems and other associated products. The core issue involves a potential electric shock hazard stemming from a faulty cable in the Eaton 9130 voltage regulator, an integral component of the affected systems. GE Medical Systems, LLC identified that this cable might not be properly connected, which could pose an electric shock risk if the voltage regulator cable is unplugged. The company confirmed that no injuries have been reported due to this defect. This NMPA filing serves as a regulatory report concerning an international recall. While GE Medical Systems Trading Development (Shanghai) Co., Ltd. reported this recall to the NMPA, the required actions are specifically targeted at products sold exclusively within the United States. The document explicitly states that zero affected products were sold in China, meaning no direct actions are mandated for the Chinese market under this particular recall notification.