China NMPA Product Recall - Magnetic resonance imaging system; Positron emission tomography (PET) system

On December 16, 2019, GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Magnetic Resonance Imaging (MRI) Systems and Positron Emission Magnetic Resonance Imaging Systems. This action was prompted by recent findings that specific master switch panels (MDPs), sourced from third-party suppliers, did not meet GE Healthcare’s pre-installation quality standards. The critical issue identified is the failure of these MDPs to disconnect power to the Heat Exchanger Cabinet (HEC) when the Emergency Off (E-Off) circuit is activated, posing a potential safety risk. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA). GE Healthcare is taking corrective measures by voluntarily recalling the affected medical devices to ensure patient safety and product integrity. Further details regarding the specific models, specifications, and batches involved are outlined in the "Medical Device Recall Event Report Form".