China NMPA Product Recall - Nuclear magnetic resonance system, nuclear magnetic resonance imaging system, magnetic resonance imaging system, positron emission tomography (PET) imaging system

GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Positron Emission Magnetic Resonance Imaging Systems (PETS) and other related MRI systems on February 9, 2022. The recall notice was subsequently issued on February 13, 2022, following initiation by the Shanghai Municipal Drug Administration. The primary safety concern identified by the company involves the potential release of refrigerant gas into the Magnetic Resonance (MR) room during a magnet quenching event. This gas release could lead to an oxygen-deficient environment, posing significant safety risks, particularly in locations with poor ventilation. The recall addresses this critical issue to prevent potential harm to patients and operators. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) and was prompted by the Shanghai Municipal Drug Administration. The voluntary recall, classified as Level II, indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. Specific details regarding the affected models, specifications, and batch numbers are provided in an accompanying "Medical Device Recall Event Report Form" for stakeholders to consult. The company is taking proactive steps to mitigate the identified safety hazard associated with its imaging systems.