# China NMPA Product Recall - Patient monitor

Source: https://www.keypedia.com/records/china_product_recall/philips-china-investment-co-ltd/638f75b8-5c93-4bac-b6e9-4a25046f800f
Source feed: China

> China NMPA product recall for Patient monitor by Philips (China) Investment Co., Ltd. published December 11, 2018. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its MX40 patient moni

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient monitors
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2018-12-11
- Product Name: Patient monitor
- Recall Level: Level 3 Recall
- Recall Reason: When the product is running in monitored mode at an altitude above 4,500 feet (1,372 meters), the volume of the speaker on the MX40 (model: 865351, 865352) manufactured between February 21, 2017 and August 22, 2018 may be reduced or become inaudible.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its MX40 patient monitors (models 865351, 865352), as announced by the National Medical Products Administration (NMPA) on December 11, 2018. This action follows the Shanghai Food and Drug Administration Medical Device Recall 2018-285. The recall addresses a critical issue where, during operation at altitudes exceeding 4500 feet (1372 meters), the device's speaker volume may become reduced or completely inaudible. This defect impacts products manufactured between February 21, 2017, and August 22, 2018, posing a significant safety risk if medical personnel cannot hear essential alarms or alerts. The company has taken responsibility for identifying and addressing this performance deviation under the NMPA's regulatory oversight. The recall mandates the retrieval of all affected units, with detailed information on specific models, specifications, and batches provided in the accompanying "Recall Event Report Form." This proactive measure aims to mitigate potential patient safety concerns stemming from compromised audible alerts in high-altitude clinical settings.

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