# China NMPA Product Recall - electrocardiograph

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/011de922-d77b-430e-9325-937476ebef2b/
Source feed: China

> China NMPA product recall for electrocardiograph by Philips (China) Investment Co., Ltd. published January 15, 2019. Recall level: Level 2 Recall. On January 15, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling Electrocardiograph machines.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-01-15
- Product Name: electrocardiograph
- Recall Level: Level 2 Recall
- Recall Reason: The lithium-ion battery in the electrocardiograph overheated and burned, indicating that the battery had exceeded its expected lifespan; the current label does not include complete instructions on how to use this information to determine when to replace the battery.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On January 15, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its electrocardiograph (ECG) machines, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stemmed from internal product complaints revealing that the lithium-ion batteries in these ECG devices were overheating and burning, exceeding their expected operational lifespan. A primary issue identified was incomplete product labeling. The existing instructions failed to provide clear guidance on when to replace the battery, specifically omitting criteria such as exceeding 300 charge-discharge cycles or when battery capacity drops below 80% of a new battery. This lack of comprehensive instructions meant users might not replace batteries at the appropriate time, potentially leading to safety concerns. As a required action, Philips (China) Investment Co., Ltd. is recalling affected electrocardiograph models. Detailed information regarding the specific models, specifications, and batches involved in this recall is accessible in the accompanying "Medical Device Recall Event Report Form".

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/