# China NMPA Product Recall - electrocardiograph

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/2cef0e9e-8c3e-429c-a5a1-bd88d7100c02/
Source feed: China

> China NMPA product recall for electrocardiograph by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published August 06, 2021. Recall level: Level 2 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Class II recall of its elect

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. voluntarily recalls electrocardiograph machines
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2021-08-06
- Product Name: electrocardiograph
- Recall Level: Level 2 Recall
- Recall Reason: The lithium battery used with this product may overheat or burn after its service life has expired.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Class II recall of its electrocardiographs following reports that the lithium batteries within these devices may overheat or ignite once they exceed their service life. This action, reported to the National Medical Products Administration (NMPA) on August 6, 2021, addresses a significant safety concern for product users. The recall impacts specific models, including TC20, 30, 50, and 70 ECG Machines. As part of the corrective measures, Philips Kinco is implementing a software upgrade focused on battery management for the affected units. This proactive recall demonstrates the company's commitment to product safety and compliance with regulatory standards, aiming to mitigate potential risks associated with battery malfunction and ensure the continued safe operation of its medical devices. Detailed information regarding the specific batches and models affected is available in the Medical Device Recall Event Report Form.

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