# China NMPA Product Recall - Non-invasive ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenyang-siasun-medical-technology-co-ltd/8771a423-4541-4b03-b644-4b65b5fd01be/
Source feed: China

> China NMPA product recall for Non-invasive ventilator by Shenyang Siasun Medical Technology Co., Ltd. published August 23, 2019. Recall level: Level 3 Recall. Shenyang Siasun Medical Technology Co., Ltd. initiated a voluntary Level III recall for its non-inva

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenyang Siasun Medical Technology Co., Ltd. voluntarily recalls non-invasive ventilators
- Company Name: Shenyang Siasun Medical Technology Co., Ltd.
- Publication Date: 2019-08-23
- Product Name: Non-invasive ventilator
- Recall Level: Level 3 Recall
- Recall Reason: The non-invasive ventilator's air inlet and outlet lack "fresh gas inhalation" and "gas output" labels.
- Discovering Company: Shenyang Siasun Medical Technology Co., Ltd.
- Manufacturing Company: Shenyang Siasun Medical Technology Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/shenyang-siasun-medical-technology-co-ltd/14de7051-1af5-4a4c-bb5c-6358a3a63cdb/