# China NMPA Product Recall - Patient Monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/e3608537-f9c3-4818-9715-10c45500ca7f
Source feed: China

> China NMPA product recall for Patient Monitor by Philips (China) Investment Co., Ltd. published April 16, 2019. Recall level: Level 2 Recall. On April 16, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of its Patient Monitor devices.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-04-16
- Product Name: Patient Monitor
- Recall Level: Level 2 Recall
- Recall Reason: The battery power consumption of the affected products may be too high. For MX40 models with software revision B installed, the duration of a fully charged battery is reduced by approximately 25% compared to the time specified in the MX40 user manual. This issue affects the operation of MX40 models powered by both rechargeable and disposable batteries; low battery warnings are not issued as specified in the user manual.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On April 16, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its Patient Monitor, specifically targeting MX40 models with software revision B. This action was prompted by identified performance issues related to the devices' battery system. The main concern is an elevated battery power consumption, which causes a substantial reduction in the monitors' operational duration; affected MX40 units experience approximately 25% less battery life than specified in the instruction manual. Critically, these devices also fail to issue a low battery alarm as intended, potentially compromising timely user intervention. This issue impacts both rechargeable and disposable battery operations. The National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration are overseeing this recall. Philips (China) has detailed the affected models, specifications, and batch numbers in a 'Medical Device Recall Event Report Form' to facilitate this necessary corrective action for the registered medical device 20173216825, prioritizing patient safety.

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