# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/ab93a9dd-96ea-4c23-99e5-39fda2bae9f3/
Source feed: China

> China NMPA product recall for Ventilator by Philips (China) Investment Co., Ltd. published November 13, 2017. Recall level: Level 2 Recall. On November 13, 2017, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls ventilators
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: Some positive airway pressure ventilators do not comply with the national mandatory standard YY-0461-2003 "Breathing Circuits for Anesthesia Machines and Ventilators" regarding the requirement to indicate the fixed flow rate in the instruction manual.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On November 13, 2017, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for several models of its positive airway pressure ventilators. This action was taken because the instruction manuals for these devices did not meet the requirements of national mandatory standard YY-0461-2003, specifically regarding the proper indication of fixed flow rates. The affected ventilators, identified by multiple national medical device registration certificates (e.g., 20162540806, 2013 No. 3545478, among others), were reported to the National Medical Products Administration (NMPA). The recall highlights a deficiency in documentation rather than a device malfunction. The company's required action is to conduct this voluntary recall, with specific details on affected product models and batches available in the accompanying "Medical Device Recall Event Report Form" attachments. This measure ensures adherence to national safety standards and clarifies operational information for users.

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