China NMPA Product Recall - Non-invasive ventilator

Shenyang Siasun Medical Technology Co., Ltd. initiated a voluntary Level III recall for its non-invasive ventilators, as reported by the National Medical Products Administration (NMPA) on August 23, 2019. The primary issue prompting this action was the absence of crucial "fresh gas inhalation" and "gas output" markings on the air inlet and outlet of the affected devices. This labeling deficiency, identified by the company itself, could potentially lead to user confusion regarding the ventilator's proper operation and connection. The regulatory framework for this action involves the NMPA and the Liaoning Provincial Drug Administration, under whose authority the device was originally approved (Registration No.: Liaoning Food and Drug Administration Medical Device (Approval) No. 20142540117). As a Level III recall, the regulatory body deemed the likelihood of adverse health consequences from this defect to be low. The required action for Shenyang Siasun Medical Technology Co., Ltd. was to execute this voluntary recall to rectify the non-compliance and uphold product safety standards. Further product-specific details are available through the NMPA's "Medical Device Recall Events" section.