China NMPA Product Recall - surgical microscope

Zhenjiang Yihua Optical Instrument Co., Ltd. initiated a Level 3 voluntary recall for its TH-X-4A Surgical Microscopes (Registration Certificate Code: Su Xie Zhu Zhun 20142220213). This action followed a National Medical Device Spot Check conducted by the Pharmaceutical and Instrument Testing Institute between May 25 and September 4, 2018. The inspection identified critical non-compliance issues concerning the equipment's external markings. Specifically, the sample unit was found to have a "missing bulb position and horizontal arm lifting safety device," "inadequate marking of corresponding hazards," and an "unmarked power supply current type." Operating under the National Medical Products Administration (NMPA) framework, the company's required corrective actions include replacing non-compliant labels with new ones and significantly strengthening finished product inspection procedures to mitigate product risks and ensure regulatory adherence. Importantly, the single affected unit was a sample and had not been sold to the public, remaining with the testing institute.