China NMPA Product Recall - Surgical power system

Medtronic Xomed, Inc., supported by Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its surgical power systems. Announced by the National Medical Products Administration (NMPA) on September 6, 2023, this action addresses a critical operational anomaly. The primary issue identified is that the M5 micro-slicer component within the surgical power systems was found to rotate at a speed exceeding the setting on its control panel. This deviation presents a potential safety risk during surgical procedures. The recall pertains to devices registered under National Medical Device Registration Certificates 20172547247 and 20172547249. A Class II recall indicates that the product's use may lead to temporary or medically reversible adverse health consequences, or where serious adverse health consequences are remote. Medtronic's proactive measure ensures compliance with NMPA regulatory standards and emphasizes product safety. Healthcare facilities and users are directed to the "Medical Device Recall Event Report Form" for comprehensive details regarding affected product models, specifications, and batches, along with necessary instructions.