China NMPA Product Recall - surgical microscope

Zhenjiang Zhuochuang Medical Technology Co., Ltd. initiated a voluntary Level 3 recall of its ZC-X-4A surgical microscopes (Registration Certificate: Su Xie Zhu Zhun 20182) following a national medical device spot check. The inspection, conducted by the Health Bureau's Drug and Instrument Testing Institute of the General Logistics Department of the Central Military Commission between May 25 and September 7, 2018, revealed a critical non-compliance. The primary issue identified was that the "external markings of equipment or equipment components" failed to meet required standards. Specifically, the product lacked appropriate hazard markings for the replacement bulb position and the safety device for the horizontal arm lifting. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA). The affected product was a single sample unit from batch 20180056, which had not been sold commercially but was held for testing. As part of the required corrective actions, Zhenjiang Zhuochuang Medical Technology Co., Ltd. will retrieve the original sample unit. The company commits to re-affixing the necessary warning labels to address the identified safety deficiencies. This proactive measure ensures compliance with safety standards, despite the limited scope of affected units. The recall report was dated December 10, 2018, and published on December 12, 2018.