China NMPA Product Recall - Leica M220 F12 Surgical Microscope

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its M220 F12 surgical microscopes, manufactured before March 9, 2017. This action, published by the National Medical Products Administration (NMPA) on November 17, 2021, follows a complaint received in May 2021 regarding the M220 F12 system. The complaint identified a potential safety hazard related to mechanical component failure, although no patient injuries were reported. Under the regulatory oversight of the NMPA and the Shanghai Municipal Drug Administration, Leica Microsystems (Shanghai) Trading Co., Ltd. is undertaking this recall to address the identified product deficiency. The required actions involve inspecting all affected surgical microscopes and subsequently upgrading their spare parts to prevent future mechanical failures and ensure product safety. Detailed information on affected models and batches is accessible through the 'Medical Device Recall Event Report Form'.