# China NMPA Product Recall - Ventilator

Source: https://www.keypedia.com/records/china_product_recall/philips-china-investment-co-ltd/38b59d4f-7ec3-4c36-8b35-bb03e8c95c21
Source feed: China

> China NMPA product recall for Ventilator by Philips (China) Investment Co., Ltd. published October 17, 2019. Recall level: Level 2 Recall. On October 17, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of s

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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: 2019-10-17
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The issue affecting some Philips V60 ventilators is a potential risk to patients or users. Certain treatment settings require the use of the touchscreen for changes. The touchscreen in affected devices may become unresponsive and fail to react to touch commands. Therefore, patients may be unable to change ventilator treatment settings (e.g., FiO2). While users may immediately detect the touchscreen malfunction, they will not receive advance warnings.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On October 17, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of specific ventilators, as reported by the National Medical Products Administration (NMPA). The recall stems from a critical issue identified in some Philips V60 ventilators where the touchscreen may become unresponsive. This malfunction directly impacts patient care by preventing users from adjusting crucial treatment settings, such as FiO2, which could pose a risk to patients. While the unresponsiveness of the touchscreen is immediately detectable, users receive no prior warning regarding the impending failure. This voluntary action, detailed under Shanghai Food and Drug Administration Medical Device Registration Certificate 2019-251, requires the company to retrieve affected devices, identified by Registration Certificate No.: 20163545139. Further comprehensive details regarding the specific models, specifications, and batch numbers of the recalled products are available in an associated 'Medical Device Recall Event Report Form' that accompanies the announcement. This proactive measure by Philips aims to mitigate potential patient safety concerns arising from the identified device malfunction.

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