China NMPA Product Recall - emergency ventilator

Viman (Shanghai) Medical Device Trading Co., Ltd. initiated a voluntary Class III recall of its emergency ventilators (Registration Certificate No.: 国械注进20153080367), as reported on April 19, 2021, under the National Medical Products Administration (NMPA). This action followed a routine internal quality check at Viman's headquarters, which uncovered a potential issue: in extremely rare instances, the device might experience a black screen and cease ventilation during operation, triggering audible and LED light alarms and rendering it unusable. This preventative measure was taken despite Viman having received no user feedback or adverse event reports globally regarding this specific problem at the time of the recall notice. Operating within the NMPA's regulatory framework, the company proactively addressed the identified product defect. Viman's required actions involve recalling affected emergency ventilator models, specifications, and batches, with comprehensive details provided in the "Medical Device Recall Event Report Form" attachment. This recall highlights the critical role of continuous internal quality assurance in ensuring product reliability and patient safety within the medical device industry.