China NMPA Product Recall - X-ray tube assembly

On May 6, 2021, Wanrui Vision Imaging Equipment (China) Co., Ltd. initiated a voluntary Level III recall for 33 units of its X-ray tube assemblies distributed in China. This action, overseen by the National Medical Products Administration (NMPA), stemmed from internal testing that identified an error on the product labels. The primary issue involved the incorrect printing of the registration certificate number and the last digit of the product technical requirements number.

Crucially, the company confirmed that this labeling discrepancy does not affect the safety or performance of the X-ray tube assemblies. Therefore, the recall is administrative in nature, addressing a documentation inaccuracy rather than a product defect. As part of the required actions, Wanrui Vision is implementing on-site improvement measures and directly contacting affected customers. The objective is to provide correct product information and update labels on-site. This proactive measure ensures adherence to regulatory standards for product information accuracy within the Chinese medical device market.