China NMPA Product Recall - Leica M220 F12 Surgical Microscope

Leica Microsystems (Shanghai) Trading Co., Ltd. has initiated a voluntary Class II recall of its Leica M220 F12 surgical microscopes, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on May 6, 2021. The core issue is a mechanical component failure in the rocker arm, specifically due to insufficient tightening of screws connecting the rocker arm and the primary lens, which could potentially cause patient injury.

This action follows a previous voluntary recall (reported in February 2019 and completed by June 2020) that aimed to address the same problem. However, a subsequent complaint revealed that the method used during the earlier recall, where authorized on-site representatives assessed screw connection reliability, was insufficient. This inadequacy meant the stability of the M220 primary lens could not be guaranteed throughout the instrument's expected service life.

As a result, Leica Microsystems is now recalling all M220 F12 surgical microscopes with assembly serial numbers lower than S/N 5142, manufactured between March 9, 2017, and October 31, 2018. This comprehensive recall is a proactive measure to ensure patient safety and maintain customer satisfaction, addressing the persistent risk despite prior intervention. Further details on affected products are provided in the associated "Medical Device Recall Event Report Form."