# China NMPA Product Recall - Arm-type electronic blood pressure monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangzhou-tongsheng-electronic-technology-co-ltd/93026e0a-b55b-4220-93c8-9e1be6933f6e/
Source feed: China

> China NMPA product recall for Arm-type electronic blood pressure monitor by Guangzhou Tongsheng Electronic Technology Co., Ltd. published December 20, 2018. Recall level: Level 3 Recall. Guangzhou Tongsheng Electronic Technology Co., Ltd. initiated a voluntary Level 3 recall for its arm

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangzhou Tongsheng Electronic Technology Co., Ltd. is voluntarily recalling its arm-type electronic blood pressure monitors.
- Company Name: Guangzhou Tongsheng Electronic Technology Co., Ltd.
- Publication Date: 2018-12-20
- Product Name: Arm-type electronic blood pressure monitor
- Recall Level: Level 3 Recall
- Recall Reason: The description of concern rate in the product manual differs from the description of product technical requirements.
- Discovering Company: Guangzhou Tongsheng Electronic Technology Co., Ltd.
- Manufacturing Company: Guangzhou Tongsheng Electronic Technology Co., Ltd.
- Summary: Guangzhou Tongsheng Electronic Technology Co., Ltd. initiated a voluntary Level 3 recall for its arm-type electronic blood pressure monitors, specifically model TSB-602, batch Q18314A1. This action, reported to China's National Medical Products Administration (NMPA) and the relevant Provincial Food and Drug Administration, stemmed from a critical discrepancy in the product's instruction manual. The issue identified was that the heart rate description in the manual did not align with the product's technical requirements. More specifically, the manual failed to adequately inform users that measurements might be inaccurate or impossible when individuals experience common heart rhythm disorders such as premature atrial contractions, premature ventricular contractions, or atrial fibrillation.

Company: https://www.globalkeysolutions.net/companies/guangzhou-tongsheng-electronic-technology-co-ltd/6d057642-4d0f-40d1-a1a5-39d4d41c1c06/