# China NMPA Product Recall - V60 ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/9b42b8e2-f9d9-4a91-b592-20bf093be9eb/
Source feed: China

> China NMPA product recall for V60 ventilator by Philips (China) Investment Co., Ltd. published April 10, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class 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: 2020-04-10
- Product Name: V60 ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The V60 ventilator is susceptible to premature failure. A soldered connection (connection assembly R31) on the V60's first-generation power management printed circuit board may malfunction. This failure could cause turbine power failure, deceleration, and trigger a high-priority alarm; in rare cases, a disconnection failure mode may occur, disrupting normal ventilator operation and causing the ventilator to shut down unexpectedly without alarms.
- 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 of its V60 ventilators, as reported by the National Medical Products Administration (NMPA) on April 10, 2020. The recall stems from a critical manufacturing defect involving a solder joint (R31) on the first-generation power management printed circuit board. This defect can lead to premature failure of the ventilator. The primary issue is the potential for the turbine to lose power and decelerate, triggering a high-priority "Check Ventilator" visual and audible alarm. Clinicians are advised to immediately transfer patients to a standby ventilator in such events. A more severe, albeit rare, scenario involves a complete disconnection failure mode, which can cause the ventilator to shut down unexpectedly without any alarm. The company's action falls under NMPA's regulatory oversight for medical devices. Further details regarding the specific models, specifications, and batches affected are available in the accompanying "Medical Device Recall Event Report Form".

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