# China NMPA Product Recall - Ventilator

Source: https://www.keypedia.com/records/china_product_recall/philips-china-investment-co-ltd/3660b8ad-68e0-4de1-96ec-d4d84f798e28
Source feed: China

> China NMPA product recall for Ventilator by Philips (China) Investment Co., Ltd. published November 19, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of its V60 ventilators, 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: 2020-11-19
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: There are two potential problems with the backup battery for the V60 ventilator: 1. If the battery is over-discharged, the ventilator may display a battery malfunction alarm; 2. If the ventilator is stored for an extended period without being plugged into AC power, the battery may not be able to be recharged.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of its V60 ventilators, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on November 19, 2020. The recall stems from two identified potential problems with the ventilator's backup battery. Firstly, if the battery undergoes over-discharge, the device may activate a battery malfunction alarm, potentially affecting operational continuity. Secondly, extended storage of the ventilator without being connected to an AC power source could lead to the battery becoming unchargeable, rendering the backup power supply ineffective when needed. Importantly, Philips has confirmed that no adverse events related to these battery malfunctions have been reported to date. This proactive measure ensures compliance with medical device regulations by addressing potential product deficiencies to safeguard patient care. Detailed information regarding specific product models, specifications, and batch numbers involved in this recall is available in the accompanying "Medical Device Recall Event Report Form".

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