China NMPA Product Recall - surgical microscope

Leica Microsystems (Shanghai) Trading Co., Ltd. has initiated a voluntary Class II recall of its surgical microscopes, as reported on April 19, 2019. This action stems from a series of complaints received between 2010 and 2017, highlighting a critical issue where the surgical microscopes would tilt when the arm was fully extended. This defect raises concerns about the stability and safe operation of the devices during medical procedures. The recall is conducted under the regulatory framework of the National Medical Products Administration (NMPA) and references Medical Device Registration Certificate No. 20162221105. A Class II recall indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling the affected products. Detailed information regarding the specific models, specifications, and batch numbers of the recalled microscopes is available in the associated Medical Device Recall Event Report Form for stakeholders to review.