# China NMPA Product Recall - Ultrasonic Doppler fetal heart rate monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-yagao-technology-co-ltd/d8c75ed3-cd84-48a9-b25c-9efcd84694ae/
Source feed: China

> China NMPA product recall for Ultrasonic Doppler fetal heart rate monitor by Shenzhen Yagao Technology Co., Ltd. published July 29, 2019. Recall level: Level 3. Shenzhen Anbao Technology Co., Ltd. initiated a voluntary Level III recall for one unit of its Ultra

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Anbao Technology Co., Ltd. is voluntarily recalling its ultrasonic Doppler fetal heart rate monitors.
- Company Name: Shenzhen Yagao Technology Co., Ltd.
- Publication Date: 2019-07-29
- Product Name: Ultrasonic Doppler fetal heart rate monitor
- Recall Level: Level 3
- Recall Reason: The product label contains incorrect information symbols, and the instruction manual lacks technical data regarding sound output levels.
- Discovering Company: Shenzhen Anbao Technology Co., Ltd.
- Manufacturing Company: Shenzhen Yagao Technology Co., Ltd.
- Summary: Shenzhen Anbao Technology Co., Ltd. initiated a voluntary Level III recall for one unit of its Ultrasonic Doppler Fetal Heart Rate Monitor (Registration Certificate No.: 粤械注准20172231485号), as reported on July 24, 2019. This action was undertaken in response to identified non-conformities with regulatory requirements governing medical devices. The primary issues involved incorrect label information symbols on the product and the omission of critical technical data regarding sound output levels within the instruction manual. Operating under the oversight of the National Medical Products Administration (NMPA), referenced by Index No. JGXX-2019-10472, the company acknowledged these deficiencies. To address the violations, Shenzhen Anbao Technology Co., Ltd. has committed to a proactive recall of the affected device. Corrective actions include the replacement of the non-compliant product label and a revision of the instruction manual to incorporate the previously missing technical data on sound output levels. This ensures the device meets safety and information disclosure standards, providing complete and accurate information to medical professionals using the device for detecting fetal heart rate information.

Company: https://www.globalkeysolutions.net/companies/shenzhen-yagao-technology-co-ltd/7fcd70af-4473-4c2e-8dba-56a16482182b/