China NMPA Product Recall - Ventilator System

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its 980 Ventilator System, as reported by the National Medical Products Administration (NMPA) on March 1, 2021. The recall stems from eight global reports, beginning in July 2019, concerning overheating or thermal damage to the battery packs within the 980 ventilators. With over 45,000 battery packs installed worldwide, the company identified a critical safety concern requiring immediate action. Under the guidance of the NMPA, Covidien's primary corrective measure involves releasing a software update designed to resolve the battery thermal issues across all affected 980 ventilator units. This recall specifically targets the Ventilator System with Registration Certificate No.: 20193080214. Notably, this action does not necessitate product returns; instead, the focus is on implementing the software solution to mitigate the identified safety risk. The "Medical Device Recall Event Report Form" contains further specifics on models, specifications, and batches involved in this important safety initiative.