China NMPA Product Recall - X-ray computed tomography equipment, computed tomography scanning system

This document, published by the National Medical Products Administration (NMPA) on December 5, 2018, details a voluntary Class II recall initiated by Philips (China) Investment Co., Ltd. The recall addresses a critical safety concern involving specific models of X-ray computed tomography (CT) equipment and CT scanning systems. The primary issue identified is the potential for the front cover of the gantry to detach. Investigations revealed that this problem stems from a specific supplier, where the glass fiber at the connection point with the gantry frame weakens, leading to the cover separating and falling. This malfunction presents a significant risk to both patients and users of the equipment. Philips (China) Investment Co., Ltd. is proactively recalling the affected devices, which include various CT equipment and CT scanning systems referenced by specific CFDA registration numbers. The recall is managed under the NMPA's regulatory framework, specifically referenced by NMPA Index No. JGXX-2018-11415 and Shanghai Food and Drug Administration Medical Device Recall 2018-277. Further details regarding affected product models are available in the attached "Medical Device Recall Event Report Form."