China NMPA Product Recall - X-ray tube assembly

Vanward Imaging Equipment (China) Co., Ltd., also known as Varex Imaging Equipment (China) Co., Ltd., has initiated a voluntary Level III recall for its X-ray tube assemblies. This action, reported to the National Medical Products Administration (NMPA) on August 16, 2022, was prompted by an internal discovery during product testing. The company identified an inaccuracy on the main label of the X-ray tube assemblies. Importantly, Vanward Imaging Equipment has clarified that this labeling error does not compromise the safety or performance of the product. The recall pertains to 70 units of various X-ray tube assembly models, which are intended for use in conventional X-ray imaging diagnostic equipment and computational tomography (CT) systems. As a required action, the company has issued a notification letter to all its distributors, informing them of the identified labeling discrepancy. This proactive measure aligns with medical device recall protocols under the NMPA's regulatory oversight, demonstrating the company's commitment to transparency regarding product information, even for issues not directly impacting patient safety.