China NMPA Product Recall - Medical Magnetic Resonance Imaging System

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its medical magnetic resonance imaging (MRI) systems, publicly announced on January 10, 2019, under the National Medical Products Administration (NMPA) framework. The recall addresses a safety issue where ceiling-mounted speakers, standard equipment in their MRI systems, may detach from their mounts. This potential problem arises from external influences such as hospital facility maintenance, leaks, or reduced mounting force during the MRI system's lifespan, despite Philips' Planning Reference Data specifying ceiling strength requirements. Once detached, these speakers can be attracted to the powerful magnetic field of the MRI unit, posing a risk to patients or users. To date, one global injury incident related to a falling speaker has been reported. Philips is recalling multiple models and batches of its Medical MRI Systems, identified by various registration certificate numbers, with specific details available in the 'Medical Device Recall Event Report Form,' to mitigate this potential hazard and ensure patient safety.