China NMPA Product Recall - X-ray computed tomography (CT) system

Philips (China) Investment Co., Ltd. and its manufacturer, Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall of specific X-ray Computed Tomography (CT) Systems. This action, published by the National Medical Products Administration (NMPA) and Shanghai Municipal Food and Drug Administration on December 22, 2014, followed an internal report on December 12, 2014. The recall addresses a potential defect in the vertical motor/brake of patient stents/scanning beds within certain production batches. This issue could lead to uninstructed vertical movement of the scanning bed, posing a potential risk of injury to patients, technicians, or other users near the equipment. Despite no reported injuries associated with this malfunction, the company proactively identified the hazard. The regulatory framework for this recall is established by the NMPA, overseeing medical device safety in China. As a required action, Philips is implementing corrective measures, deploying field service engineers to repair all 148 affected CT units sold in China. These repairs will utilize field change orders to rectify the vertical motor/brake issue, ensuring the safe and proper functioning of the scanning beds and mitigating potential user harm.