China NMPA Product Recall - X-ray computed tomography device

Shenyang Neusoft Medical Systems Co., Ltd. initiated a Class III voluntary recall for one unit of its NeuViz Dual (1) X-ray Computed Tomography device (model NDLCN160003), as reported to the National Medical Products Administration (NMPA) on January 23, 2019, with the recall notice published on January 29, 2019. The recall stems from minor printing errors identified on both the whole machine label and the main control panel label of the affected device. The company clarified that these labeling discrepancies are purely administrative and have no impact on the performance, quality, or safe operation of the CT unit or its accessories, confirming the product continues to meet all registered standards. As part of the corrective actions, Shenyang Neusoft Medical Systems Co., Ltd. is issuing a formal 'Recall Notice' to the user of the affected unit. Furthermore, a service engineer will be dispatched to the site to physically replace the erroneous labels. Importantly, this recall does not necessitate the return or recycling of the product, and the equipment remains fully functional for normal use.