China NMPA Product Recall - surgical microscope

On February 28, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its surgical microscopes. This action was prompted by a critical safety concern involving insufficient tightening of screws that connect the rocker arm to the main mirror in the M220 model of these devices. The defect poses a significant risk, as it could lead to the main mirror detaching and falling into the sterile surgical field, potentially causing serious injury to patients during medical procedures. The recall, reported under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, applies to surgical microscopes identified by Registration Certificate No. 20172221149. Leica Microsystems (Shanghai) Trading Co., Ltd. is responsible for implementing this recall to address the identified product deficiency. Specific details regarding the affected product models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This measure underscores the commitment to patient safety and adherence to product quality standards within the medical device industry.