China NMPA Product Recall - Medical magnetic resonance imaging system

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its medical magnetic resonance imaging (MRI) systems, as reported on August 4, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an identified manufacturing error in the magnet assembly of affected products. Specifically, a 42 psi pressure reducing valve was incorrectly installed instead of the required 3.75 psi valve. This discrepancy means that while a 3.75 psi valve would release helium pressure as expected, the incorrectly installed 42 psi valve would not activate until helium pressure reached a significantly higher level. Although all affected devices include a secondary 5 psi pressure reducing valve to mitigate high-pressure helium release, ensuring appropriate amounts of helium are still released, the primary issue necessitated the recall. The affected MRI systems are identified by multiple registration certificate numbers. As of July 2021, the company had not received any user complaints directly related to this specific issue. Philips (China) is undertaking this action under the regulatory oversight of the NMPA, with detailed product information available in the "Medical Device Recall Event Report Form".