# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/79073449-576a-4d16-a6fa-5619d9ce7c4a/
Source feed: China

> China NMPA product recall for Patient monitor by Philips Medical Systems published March 08, 2019. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) in China published details on March 8, 2019, reg

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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: 2019-03-08
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: A batch of rechargeable lithium-ion batteries used in the Philips MX40 patient monitor has a manufacturing defect that may affect the monitor's operation. The affected lithium-ion batteries are currently under investigation by the supplier for their poor manufacturing process; this batch of batteries does not meet Philips' quality standards.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: The National Medical Products Administration (NMPA) in China published details on March 8, 2019, regarding a voluntary Class II recall initiated by Philips Medical Systems. The recall, reported by Philips (China) Investment Co., Ltd. on February 19, 2019, addresses patient monitors (National Medical Device Registration Certificate 20173216825), specifically models 865351 and 865352, including the Philips MX40. The primary issue identified was a manufacturing defect in a specific batch of rechargeable lithium-ion batteries. This defect could potentially impair the operational functionality of the patient monitors. Philips stated that these affected batteries did not meet their internal quality standards, prompting the recall. The investigation into the defective manufacturing process by the battery supplier is ongoing. While the recall pertains to devices intended for ECG and SpO2 monitoring in adults and children within hospital settings and during transfers, it is crucial to note that the affected batches were not sold in China. Consequently, zero units of the recalled product were distributed within the Chinese market, as confirmed by Philips' report to the NMPA. This NMPA documentation serves as a record of Philips' compliance with regulatory reporting requirements for such international product safety events. The required action by Philips was a voluntary recall of the affected product in regions like the USA, where the defective units were distributed.

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