# China NMPA Product Recall - oxygen concentrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/37999594-e210-4cee-90ba-7f0b760989b2/
Source feed: China

> China NMPA product recall for oxygen concentrator by Philips (China) Investment Co., Ltd. published November 13, 2017. Recall level: Level 3. Philips (China) Investment Co., Ltd. has initiated a voluntary Class III recall of specific oxygen c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls oxygen concentrators
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: oxygen concentrator
- Recall Level: Level 3
- Recall Reason: The product in question failed to promptly update its Chinese labeling after obtaining a new product registration certificate.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. has initiated a voluntary Class III recall of specific oxygen concentrators. This action, reported by the National Medical Products Administration (NMPA) on November 13, 2017, addresses a key regulatory compliance issue. The company failed to promptly update the Chinese labels on its oxygen concentrators after obtaining new product registration certificates, specifically for products registered under National Medical Device Registration Certificate No. 201. This oversight meant that essential updated product information was not accurately reflected on the labels in a timely manner. While no specific inspection dates are mentioned, the recall is a voluntary measure taken by Philips (China) under the regulatory oversight of the NMPA, which governs medical device registrations and post-market activities in China. As a required action, Philips (China) is recalling affected oxygen concentrators. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in the "Medical Device Recall Event Report Form" to ensure all non-compliant units are addressed according to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/