# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/e78518ef-1f60-4040-b308-59c6233c89bf/
Source feed: China

> China NMPA product recall for Ventilator by Philips (China) Investment Co., Ltd. published November 13, 2017. Recall level: . Philips (China) Investment Co., Ltd. initiated a voluntary recall of several ventilator models, as a

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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: 2017-11-13
- Product Name: Ventilator
- Recall Reason: The product in question, a ventilator, does not comply with the requirement in YY0461-2003 "Breathing Tubing for Anesthesia Machines and Ventilators" regarding the labeling of the rated flow rate of the breathing tubing in the instruction manual.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary recall of several ventilator models, as announced by the National Medical Products Administration (NMPA) on November 13, 2017. The recall stems from the discovery that the affected ventilators did not comply with the YY0461-2003 standard, specifically regarding the labeling of rated flow rates for breathing tubing in the instructions for use of ventilation machines and circuits. While no inspection dates were provided in the document, this non-compliance prompted the company to take corrective action under the NMPA's regulatory oversight. Philips (China) Investment Co., Ltd. is voluntarily recalling a range of ventilators, with specific details pertaining to the recall level, product models, specifications, and batch numbers documented in the 'Medical Device Recall Event Report Form' for comprehensive reference.

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