China NMPA Product Recall - Medical magnetic resonance imaging system

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific medical magnetic resonance imaging (MRI) systems, publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 20, 2021. This proactive measure addresses a potential defect within the MRI system's horizontal drive unit (HDU). The core issue involves the scanning bed potentially jamming and becoming immobile exclusively when operating in manual mode. This malfunction is attributed to the interaction between non-circular gear teeth and a slightly bent Flexrack. Notably, this problem does not affect the system's electric mode, which is the primary operational method. The manual function is intended as a backup for emergency patient evacuation or when electric movement is impaired. Despite no customer complaints related to this specific issue as of July 2021, Philips is undertaking this recall to mitigate any potential safety risks. Comprehensive details regarding the affected product models and batches are provided in an accompanying Medical Device Recall Event Report Form, ensuring adherence to regulatory standards.