China NMPA Product Recall - X-ray computed tomography equipment

On February 13, 2015, Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary recall of specific X-ray computed tomography (CT) equipment models, including Ingenuity Core/Ingenuity Core 128, Ingenuity Flex, and Brilliance CT 16. This action was announced by the National Medical Products Administration (NMPA), the overseeing regulatory body. The primary concern prompting the recall is a potential malfunction within the patient support unit's vertical motor and braking mechanism, which could result in unexpected movement. Although no injuries to patients or operators have been reported, this defect presents a risk of harm to individuals near the equipment. A total of 44 affected units were manufactured, with 27 distributed within China. To address this safety concern, Philips Healthcare (Suzhou) Co., Ltd. will deploy field service engineers to conduct on-site modifications and repairs on all impacted devices. This corrective measure aims to resolve the identified technical defect and uphold the safety and reliability standards of their medical devices.