# China NMPA Product Recall - Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/75cf4a4e-627c-4bdc-90f9-709a0485cdb2/
Source feed: China

> China NMPA product recall for Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator by Philips (China) Investment Co., Ltd. published June 16, 2021. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for multiple models of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling ventilators.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-06-16
- Product Name: Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator; Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The product in question involves polyester-based polyurethane (PE-PUR) sound-absorbing foam used in ventilators, which may pose two potential problems: 1) PE-PUR foam may degrade into particles under certain conditions, which could enter the air passage of the device and be ingested or inhaled by the user. 2) PE-PUR foam may release certain organic compounds under certain conditions.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for multiple models of its ventilators, as announced on June 16, 2021, and publicly reported by the National Medical Products Administration (NMPA) on November 5, 2021. The recall stems from two critical issues identified with the polyester polyurethane (PE-PUR) sound-absorbing foam utilized in these medical devices. Firstly, the PE-PUR foam has the potential to degrade into small particles under specific conditions. These particles may subsequently enter the equipment's air passage, posing a risk of ingestion or inhalation by users. Secondly, the foam is capable of releasing certain volatile organic compounds when exposed to particular environmental factors. Both issues present potential health hazards to patients relying on these ventilators. This action, overseen by the NMPA and originating from a report on the Shanghai Municipal Drug Administration website, covers various ventilator models, identified by multiple CFDA import/export registration certificate numbers. A Class II recall indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Comprehensive details regarding the affected product models, specifications, and specific batches are provided in the accompanying "Medical Device Recall Event Report Form," which stakeholders are advised to consult for further information.

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