# China NMPA Product Recall - Digital electrocardiograph

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangzhou-ruijiu-electronic-technology-co-ltd/db2633c5-6f5c-4293-be38-3cfa59ccade7/
Source feed: China

> China NMPA product recall for Digital electrocardiograph by Guangzhou Ruijiu Electronic Technology Co., Ltd. published September 02, 2019. Recall level: Level 3. Guangzhou Sanrui Electronics Technology Co., Ltd. initiated a voluntary Level 3 recall for its digit

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangzhou Sanrui Electronic Technology Co., Ltd. is voluntarily recalling digital electrocardiographs.
- Company Name: Guangzhou Ruijiu Electronic Technology Co., Ltd.
- Publication Date: 2019-09-02
- Product Name: Digital electrocardiograph
- Recall Level: Level 3
- Recall Reason: Our company recently discovered that two of the 19KC034 batch of digital electrocardiographs meet the requirements of 4.2.3 in the mandatory standard YY 1139-2013 regarding "input dynamic range," but do not meet the requirements of 2.2.3 in our company's product technical requirements. No customer complaints or adverse event reports have been received so far.
- Discovering Company: Guangzhou Sanrui Electronics Technology Co., Ltd.
- Manufacturing Company: Guangzhou Ruijiu Electronic Technology Co., Ltd.
- Summary: Guangzhou Sanrui Electronics Technology Co., Ltd. initiated a voluntary Level 3 recall for its digital electrocardiographs, as reported to the National Medical Products Administration (NMPA) on August 16, 2019, and published on September 2, 2019. The recall specifically targeted two units from batch 19KC034, model ECG-5512B. The primary issue was that these devices, while meeting the mandatory national standard YY 1139-2013 for "input dynamic range," did not conform to the company's own internal product technical requirements (item 2.2.3). 

The company confirmed that this was an isolated incident, had not resulted in any customer complaints or adverse event reports, and did not pose a safety risk or compromise device performance. In response, Guangzhou Sanrui Electronics Technology Co., Ltd. undertook several corrective actions: immediately notifying customers to recall the affected batch, conducting random inspections of all other digital electrocardiograph models in inventory and on the production line (which were found compliant), and analyzing the recalled products to verify the isolated nature of the deviation.

Company: https://www.globalkeysolutions.net/companies/guangzhou-ruijiu-electronic-technology-co-ltd/77af041d-52e3-4aa4-bfb5-489ee71d3eff/