China NMPA Product Recall - Medical Magnetic Resonance Imaging System

Philips Medical Systems Nederland B.V. initiated a voluntary Class II recall of its Medical Magnetic Resonance Imaging Systems. This action, reported by Philips (China) Investment Co., Ltd. and overseen by China's National Medical Products Administration (NMPA), was publicly announced on June 9, 2021, with the official recall event report form dated May 25, 2021.

The core issue identified was a manufacturing defect concerning the rotating eye bolt, a critical lifting hardware component. Specifically, the diameter of the bolt interface face did not meet the required specifications for certain models and batches of the equipment. This non-conformance could potentially impact the safe handling or installation of the devices, posing a risk of temporary or medically reversible adverse health consequences.

As a corrective measure, Philips Medical Systems Nederland B.V. is conducting this Class II recall. The company has submitted a "Medical Device Recall Event Report Form" outlining the affected products, specifications, and batches, and detailing the Field Safety Corrective Action (FCO78100524) taken to address this manufacturing deviation. This recall ensures compliance with regulatory standards and aims to mitigate potential risks associated with the faulty component.