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 December 21, 2018. The recall addresses a critical safety concern where speakers, designed for patient communication and sound, could detach from their overhead suspension within the MRI environment. This detachment risk arises from the powerful magnetic field of the MRI system, which, in rare instances, can attract falling speakers, posing a potential hazard. The affected products include various models of medical MRI systems, with 634 units specifically identified for the Chinese market as part of a global recall. To resolve this issue, Philips Healthcare (Suzhou) Co., Ltd. is taking corrective action through field updates (FCO). They are committed to notifying all affected customers and implementing necessary modifications to securely fix the speakers, thereby mitigating the risk and ensuring the safe operation of their MRI systems in clinical settings. This action underscores the company's commitment to product safety under NMPA oversight.