# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/3e1eb2ae-a25d-423e-96bd-1ae59ce47b4d/
Source feed: China

> China NMPA product recall for Patient monitor by Philips (China) Investment Co., Ltd. published June 19, 2017. Recall level: Level 3. On June 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II

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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: 2017-06-19
- Product Name: Patient monitor
- Recall Level: Level 3
- Recall Reason: The affected products may issue alarms that are not expected under standard YY1079:2008.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On June 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Philips (China) Investment Co., Ltd. for certain patient monitors. While no specific inspection dates were provided in this recall notice, the action was taken due to a critical product issue: the affected patient monitors (Registration No.: 20153212166) have the potential to issue alarms that are not expected during operation. This malfunction represents a significant deviation from the performance and safety criteria outlined in standard YY1079:2008, a key regulatory benchmark for medical devices in China. The regulatory framework under which this recall operates is overseen by the NMPA, ensuring adherence to national health and safety standards. The company's required action is to conduct a Class III recall, indicating that while the probability of serious adverse health consequences from this defect is low, corrective measures are necessary to uphold product quality and patient safety. Comprehensive details regarding the specific models, specifications, and affected batch numbers are documented within the "Medical Device Recall Event Report Form" and its associated attachments. This incident highlights the ongoing commitment by both manufacturers and regulatory bodies to maintain high standards for medical device functionality and patient trust.

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