China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall, reported to China's National Medical Products Administration (NMPA) on August 22, 2017, and publicly announced on September 4, 2017. The recall involves 47 units of their Ingenuity Core 128 X-ray computed tomography equipment, specifically those operating with software versions 4.1.6.XX030 or 4.1.6.XX032.The primary issue identified is a system error that occurs during non-gated contrast agent injection tracking (Bolus). When a clinical scan reaches its threshold, an error message appears, causing the scan sequence to be canceled and resulting in contrast agent loss. This malfunction may necessitate a rescan, potentially affecting diagnostic efficiency.In response to this problem, Philips Healthcare (Suzhou) Co., Ltd. has taken several corrective actions. These include issuing on-site safety notification letters to users of the affected equipment and implementing a specific on-site corrective action (FC072800675) to rectify the system error. These measures were voluntarily undertaken by the company to ensure device safety and compliance under the NMPA's regulatory guidelines.