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

Source: https://www.globalkeysolutions.net/records/china_product_recall/truly-instruments-shanwei-co-ltd/3b57ab35-6c44-4971-b839-e215fb24e539/
Source feed: China

> China NMPA product recall for Arm-type electronic blood pressure monitor by Truly Instruments (Shanwei) Co., Ltd. published May 26, 2022. Recall level: Level 3. Xinli Instruments (Shanwei) Co., Ltd. initiated a voluntary Level III recall for its arm-type electr

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Truly Instruments (Shanwei) Co., Ltd. is voluntarily recalling its arm-type electronic blood pressure monitors.
- Company Name: Truly Instruments (Shanwei) Co., Ltd.
- Publication Date: 2022-05-26
- Product Name: Arm-type electronic blood pressure monitor
- Recall Level: Level 3
- Recall Reason: The instruction manual lacks information on heart rate arrhythmia detection.
- Discovering Company: Truly Instruments (Shanwei) Co., Ltd.
- Manufacturing Company: Truly Instruments (Shanwei) Co., Ltd.
- Summary: Xinli Instruments (Shanwei) Co., Ltd. initiated a voluntary Level III recall for its arm-type electronic blood pressure monitors, specifically model DB71, batch number XL19A01259. This action was officially reported on January 25, 2022, and subsequently published by the National Medical Products Administration (NMPA) on May 26, 2022. The recall involves 1000 units manufactured, with 975 having been distributed and sold within China, including the Guangxi region. These blood pressure monitors are intended for adults to measure diastolic and systolic blood pressure, along with pulse rates, providing data for diagnostic reference. While the specific reason for this voluntary recall is not detailed in the public report, a Level III classification suggests that the potential use or exposure to the affected product is not anticipated to cause severe adverse health consequences. This recall is being managed under the regulatory oversight of the Guangdong Provincial Drug Administration and in accordance with the "Regulations on the Supervision and Administration of Medical Devices." Xinli Instruments (Shanwei) Co., Ltd. is responsible for implementing the necessary corrective actions and handling the recalled products as per these regulations. No specific inspection dates are provided, as this document outlines a company-initiated recall rather than an inspection report with findings.

Company: https://www.globalkeysolutions.net/companies/truly-instruments-shanwei-co-ltd/a8d6c9ca-3c9e-45be-8b0a-839ac20843ab/