# China NMPA Product Recall - electrocardiograph

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/530b80c0-5495-49a7-8f9a-2238dd169cf5/
Source feed: China

> China NMPA product recall for electrocardiograph by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published January 14, 2019. Recall level: Level 2 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall for its electroc

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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: 2019-01-14
- Product Name: electrocardiograph
- Recall Level: Level 2 Recall
- Recall Reason: The lithium batteries used in this electrocardiograph may overheat or burn after their service life has expired. These batteries should be replaced when their capacity is less than 80% or when they have reached 300 charge-discharge cycles (whichever comes first). While the electrocardiograph can display accurate battery life and charge-discharge cycles, existing service guides 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 for its electrocardiographs, including models PageWriter TC20, TC30, and TC50, with the recall event reported to the National Medical Products Administration (NMPA) on December 29, 2018. The recall, affecting 2650 units in China and globally, stemmed from a critical safety issue: the existing service guides lacked sufficient information to instruct users on monitoring battery life, charge-discharge cycles, and the appropriate time for replacement. This deficiency posed a risk of lithium batteries overheating or burning once they exceeded their service life, specifically when their capacity fell below 80% or after 300 charge-discharge cycles. In response, Philips Kinco is implementing corrective actions, including releasing a service guide appendix to provide comprehensive instructions on battery management and replacement, and deploying software upgrades to add user prompts, thereby enhancing battery life management for medical professionals. This proactive measure aims to improve product safety and ensure users have clear guidance for the safe operation and maintenance of these essential medical devices.

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