# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/9a17f89d-93c6-42a5-9788-e54e11ef9046
Source feed: China

> China NMPA product recall for Patient monitor by Philips Medical Systems published August 12, 2019. Recall level: Level 3 Recall. On August 12, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems initiates a recall of patient monitors.
- Company Name: Philips Medical Systems
- Publication Date: 2019-08-12
- Product Name: Patient monitor
- Recall Level: Level 3 Recall
- Recall Reason: The products in question may have connectors with a thickness exceeding the specified value.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: On August 12, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Philips (China) Investment Co., Ltd., on behalf of its manufacturer, Philips Medical Systems. This recall pertains to specific patient monitors (Registration Certificate No.: Guowang 20153212166) which are regulated under the NMPA's stringent medical device framework. The core issue prompting this recall is a potential manufacturing defect where the connector thickness in the affected patient monitors was found to exceed specified design values. This deviation could potentially impact the device's functionality or safety. As a required action under the NMPA’s regulatory oversight, Philips Medical Systems is conducting a voluntary recall to address this non-conformance. The official recall notification, indexed as JGXX-2019-10524, directs stakeholders to a detailed 'Medical Device Recall Event Report Form' for comprehensive information regarding the specific models, specifications, and batches of patient monitors impacted by this corrective measure. The company is responsible for ensuring the safe removal or remediation of these devices from the market to uphold patient safety standards.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47