China NMPA Product Recall - Ventilator

On August 5, 2020, Dongji Trade (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its manufactured ventilators. This action was prompted by the identification of a potential intermittent software malfunction within the devices. The recall falls under the regulatory guidance of the National Medical Products Administration (NMPA) in China, referencing index No. JGXX-2020-10373 and the Shanghai Municipal Drug Administration’s recall designation 沪药监械主召2020-156. Although specific inspection dates are not provided in the announcement, the company proactively undertook this measure to address the product deficiency. The core issue is a software defect that could compromise the safe and effective operation of the ventilators. As a required action, Dongji Trade (Shanghai) Co., Ltd. is systematically recalling all affected ventilator models, specifications, and batches. Comprehensive information regarding the specific products involved is detailed in an associated "Medical Device Recall Event Report Form" and its attachments, ensuring transparency and adherence to NMPA's medical device regulations.