China NMPA Product Recall - Ventilator

Viman (Shanghai) Medical Device Trading Co., Ltd. has initiated a voluntary Class II recall of its Ventilator ventilators (Registration Certificate No.: 20153081989). This preventative action stems from internal quality checks conducted at Viman's headquarters in 2020, which revealed that a pneumatic valve sensor from a supplier did not consistently meet quality specifications. The identified issue could, with a very low probability, cause abnormal device startup, displaying a "Device Fault" message, or lead to device malfunction accompanied by an alarm, rendering the ventilator non-functional. As of the recall notice date (March 15, 2021), Viman has not received any user feedback or adverse event reports globally related to this specific sensor issue. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA). Affected product models, specifications, and batch numbers are detailed in the "Medical Device Recall Event Report Form," which is available for download. This recall ensures patient safety by addressing a potential component defect before it leads to actual harm.