China NMPA Product Recall - Transport ventilator

Shenzhen Anbao Technology Co., Ltd. initiated a voluntary Class III recall for its AII6000B Plus transport ventilators. This action, reported on August 1, 2017, and publicized by the National Medical Products Administration (NMPA) on September 11, 2017, addresses a labeling error. The main issue was an incorrect "Product Implementation Standard Number" printed on the Chinese label, which did not fully align with the product's official registration certificate (CFDA No. 2013 No. 3540818). The company clarified that this is solely a label information error, not impacting the ventilator's performance or safe use, but it constitutes a non-compliance with regulatory labeling requirements. The recall affects seven units from one production batch. As required actions, Shenzhen Anbao Technology Co., Ltd. is notifying all affected customers in writing. Customers are not required to return the products; instead, the company will dispatch after-sales engineers to customer locations to perform on-site replacement of the incorrect labels on the main units. The original erroneous labels will be destroyed, and customers will sign a problem handling form to confirm the completion of the label update, ensuring regulatory adherence without compromising device functionality.