China NMPA Product Recall - Magnetic resonance imaging system, medical magnetic resonance imaging system

Philips Medical Systems Nederland B.V. initiated a voluntary Level I recall of its Magnetic Resonance Imaging (MRI) Systems and Medical MRI Systems, as reported by Philips (China) Investment Co., Ltd. on January 11, 2024. The recall was prompted by a critical safety concern involving the QBC sealing strip adhesive, which secures the magnet housing to the orthogonal body coil housing. This adhesive is prone to failure, creating a risk of injury to patients, particularly during the horizontal exit of the scanning bed from the MRI system’s magnet hole. The recall affects specific MRI System models, identified by National Food and Drug Administration Import Permit numbers 20043281297 (Revised) and 20043281296, and Medical MRI Systems under Import Permit No. 20083281795 and National Medical Device Registration No. 20173065. Overseen by the National Medical Products Administration (NMPA), this Level I classification signifies a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. While specific immediate user actions are detailed in an attached 'Medical Device Recall Event Report Form,' the overarching requirement is for the company to address the identified adhesive failure to prevent patient harm.