# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/d91fa24d-c495-461b-a315-e074ba4877ec/
Source feed: China

> China NMPA product recall for Patient monitor by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published January 07, 2019. Recall level: Level 2 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its patient m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. voluntarily recalls patient monitors
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2019-01-07
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: The lithium batteries used in this patient monitor may overheat or burn after their service life has expired. These batteries should be replaced when their capacity is less than 80% or after 300 charge-discharge cycles (whichever comes first). While the patient monitor can display precise battery life and charge-discharge cycles, existing service guidelines do not contain sufficient information to guide users in obtaining this information and deciding when to replace the batteries.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its patient monitors, as reported to the National Medical Products Administration (NMPA) on December 28, 2018, with the announcement published on January 7, 2019. The recall stems from a critical safety concern regarding the lithium batteries used in these devices. The primary issue identified was that the patient monitor's service guides lacked sufficient instructions for users to effectively monitor battery life and determine appropriate replacement times. Specifically, users were not adequately guided on how to obtain information regarding battery capacity or charge-discharge cycles, which are crucial for timely battery replacement (when capacity drops below 80% or after 300 cycles). This deficiency posed a risk of battery overheating or combustion after exceeding its service life. To address these issues, Philips Kinco is required to publish a service guide appendix to include comprehensive information on battery management and replacement. Additionally, the company must implement software improvements to incorporate user prompts, thereby simplifying battery life management for healthcare professionals. This recall affects various models, including CM10, CM12, CM100, CM120, and CM150, impacting a significant quantity of units in China.

Company: https://www.globalkeysolutions.net/companies/philips-kincoway-shenzhen-industrial-co-ltd/fe26b37f-e114-43d2-b1a3-85beed6a47a7/