China NMPA Product Recall - Medical magnetic resonance imaging system

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Medical Magnetic Resonance Imaging (MRI) Systems, as reported by the National Medical Products Administration (NMPA) on July 30, 2021. The recall stems from a manufacturing issue where an incorrect 42 PSI pressure relief valve was installed during the assembly of MRI magnets. This defect poses a risk if the cooling system is inactive for more than one day, potentially leading to a slight rupture in the component and an increase in helium pressure. Such an event could cause the helium ventilation duct to freeze and block, resulting in rapid helium release and the possible ejection of mechanical parts, ultimately risking the rupture of the magnet container. The recall affects 63 units globally, encompassing specific models like Prodiva 1.5T CS, Prodiva 1.5T CX, and Multiva 1.5T, identified by their serial numbers. Although no customer complaints related to this issue have been reported, Philips Healthcare (Suzhou) is proactively addressing the safety concern. Under the NMPA's regulatory guidance, the company has submitted a "Medical Device Recall Event Report Form" to the relevant provincial authority. Required actions include Philips notifying all affected users and dispatching field engineers to perform the necessary corrections on the faulty pressure relief valves.