# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/6b74f0bf-dc19-4651-82d1-deb15c08488a/
Source feed: China

> China NMPA product recall for Ventilator by Philips (China) Investment Co., Ltd. published July 06, 2020. Recall level: Level 3 Recall. On July 6, 2020, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls ventilators
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-07-06
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were found to be non-compliant with product standards because the Philips OmniLab Advanced+ device was identified as lacking the "fresh gas inhalation" label, and the device's instruction manual lacked information on noise level, maximum flow rate at a specific pressure, and pressure/volume curves.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On July 6, 2020, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its ventilators (Registration Certificate No.: 国械注进20152541271), as reported to the National Medical Products Administration (NMPA). This action was prompted by several identified product deficiencies concerning the Philips OmniLab Advanced+ device, indicating non-compliance with established product standards. The main issues included a missing "fresh gas inhalation" label within the device's identification system. Additionally, the device instructions were found to be incomplete, lacking crucial technical specifications such as the noise sound pressure level, the maximum flow rate at a specific pressure, and the pressure/volume curve. Under the regulatory oversight of the NMPA, Philips (China) is undertaking this recall to rectify these non-conformities. The company is required to furnish comprehensive details, including specific models, specifications, and batch numbers of the affected products, in a dedicated "Medical Device Recall Event Report Form" to ensure an effective recall process. This measure underscores the company's commitment to product safety and adherence to regulatory mandates in the medical device sector.

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