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

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific X-ray computed tomography (CT) equipment and X-ray computed tomography devices, as published by the National Medical Products Administration (NMPA) on November 13, 2017. The recall was prompted by reports indicating that, in rare instances, the affected products might fail to generate images during contrast agent tracking scans. This critical malfunction prevents the acquisition of raw offline reconstruction data, potentially impacting diagnostic accuracy and patient care. The recalled devices include those under National Medical Device Registration Certificate Nos. 20153300422, 20133304134, 20123303, and 20163301984. Philips (China) voluntarily undertook this action to address the identified product performance issue. The regulatory oversight for this recall falls under the NMPA, which hosts the official recall announcement and related documentation, including detailed lists of affected models, specifications, and batch numbers in the "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks associated with the equipment's inability to consistently produce necessary imaging data during specific scanning procedures.