China NMPA Product Recall - surgical microscope

Zhenjiang Xintian Medical Device Co., Ltd. initiated a Class III voluntary recall for a surgical microscope (Model XT-X-4A, Batch 20180325) following a 2018 national medical device spot check. The recall, published by the National Medical Products Administration (NMPA) on November 29, 2018, stemmed from non-compliance related to external markings. A test sample, accepted on May 22, 2018, and reported on September 5, 2018, revealed that the safety device for the lifting arm, specifically at the bulb replacement location, lacked appropriate hazard markings. This deficiency violated clause 6.1q of the GB9706.1-2007 standard, which mandates clear warning statements for physiological effects. Although only one unit, a test sample, was affected and not commercially sold, the company implemented corrective actions. These actions include selecting stronger adhesives for labels and verifying their adherence to prevent detachment. Furthermore, a strict recording system for all labels will be established, detailing usage time, recipients, and quantities, to enhance accountability and prevent future labeling issues. The NMPA oversees this regulatory action to ensure medical device compliance.