# China NMPA Product Recall - Pulse oxygen gaussometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/masimo-corporation/8b8268bf-664c-4c14-a82c-a8da87b2d90f/
Source feed: China

> China NMPA product recall for Pulse oxygen gaussometer by MASIMO CORPORATION published October 10, 2017. Recall level: Level 3. MASIMO CORPORATION, through its subsidiary MASIMO (Beijing) Medical Technology Co., Ltd., initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MASIMO CORPORATION is actively recalling pulse oximeters.
- Company Name: MASIMO CORPORATION
- Publication Date: 2017-10-10
- Product Name: Pulse oxygen gaussometer
- Recall Level: Level 3
- Recall Reason: Mycin is recalling certain touchscreen Radical-7 devices sold in China with a previous version (non-touchscreen Radical-7) registration certificate. Mycin has since obtained a new registration certificate for its touchscreen Radical-7 devices. Mycin is requesting customers to return the touchscreen Radical-7 devices sold with the previous version registration certificate so that Mycin can replace the recalled products with devices bearing the correct registration certificate.
- Discovering Company: Mycinno (Beijing) Medical Technology Co., Ltd.
- Manufacturing Company: MASIMO CORPORATION
- Summary: MASIMO CORPORATION, through its subsidiary MASIMO (Beijing) Medical Technology Co., Ltd., initiated a voluntary Class III recall of its Radical-7 touchscreen pulse carboxyoximeters in China. The National Medical Products Administration (NMPA) published this recall notice on October 10, 2017, following a report submitted by the company on September 30, 2017.The core issue stemmed from the sale of certain touchscreen Radical-7 devices in China under a registration certificate originally intended for an older, non-touchscreen version of the Radical-7. Although a new, appropriate registration certificate for the touchscreen model was later obtained, the misrepresentation of the product's certification required corrective action. This recall primarily addresses a regulatory compliance issue rather than a defect in the device's safety or performance.As part of the recall, customers are instructed to return affected touchscreen Radical-7 devices. MASIMO is committed to replacing these units with devices accompanied by the correct and valid registration certificate. The company's required actions involve collaborating with distributors to identify and notify affected customers, facilitating product replacements, conducting multiple follow-ups with distributors, and submitting weekly progress reports to the Beijing Municipal Drug Administration. A final recall report will be submitted upon completion of these actions.

Company: https://www.globalkeysolutions.net/companies/masimo-corporation/3c8a1f36-accd-4fd4-98d9-b80fa6ddd82d/