# China NMPA Product Recall - Multi-parameter patient monitor (WPM-80)

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-baisheng-medical-technology-co-ltd/4c8c052d-279c-440f-86d7-3483715e5322
Source feed: China

> China NMPA product recall for Multi-parameter patient monitor (WPM-80) by Shenzhen Baisheng Medical Technology Co., Ltd. published March 22, 2022. Recall level: Level 3. Shenzhen Huasheng Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its mul

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Huasheng Medical Technology Co., Ltd. voluntarily recalls multi-parameter patient monitors.
- Company Name: Shenzhen Baisheng Medical Technology Co., Ltd.
- Publication Date: 2022-03-22
- Product Name: Multi-parameter patient monitor (WPM-80)
- Recall Level: Level 3
- Recall Reason: Random inspections revealed that the products did not meet the required standards.
- Discovering Company: Shenzhen Huasheng Medical Technology Co., Ltd.
- Manufacturing Company: Shenzhen Baisheng Medical Technology Co., Ltd.
- Summary: Shenzhen Huasheng Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its multi-parameter patient monitor, model WPM-80. This action follows a random inspection that identified the device as non-compliant with established standards. The recall specifically targets products covered under Registration Certificate No. "粤械注准20172211167".

Published on March 22, 2022, by the National Medical Products Administration (NMPA) and sourced from the Guangdong Provincial Drug Administration website, this announcement underscores the company's commitment to product safety and quality assurance. While specific inspection dates are not detailed, the recall decision stems directly from findings of this regulatory oversight. The company is taking proactive steps to address the identified issues, ensuring patient safety is prioritized.

Detailed information regarding affected batches and specific product details are referenced in the accompanying "Medical Device Recall Event Report Form". This voluntary recall demonstrates the manufacturer's adherence to regulatory expectations and responsibility in managing product non-conformities, aligning with the regulatory framework governing medical devices in China.

Company: https://www.globalkeysolutions.net/companies/shenzhen-baisheng-medical-technology-co-ltd/9f979272-96d8-46f2-bdb2-1a3ba0587cea
