# China NMPA Product Recall - Doppler fetal heart monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-weikangming-technology-co-ltd/7ad579bb-93ff-402d-9e91-f01d1303f088/
Source feed: China

> China NMPA product recall for Doppler fetal heart monitor by Shenzhen Weikangming Technology Co., Ltd. published August 14, 2019. Recall level: Level 3. Shenzhen Weikangming Technology Co., Ltd. initiated a voluntary Level III recall of its Doppler Feta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Weikangming Technology Co., Ltd. is voluntarily recalling its Doppler fetal heart monitors.
- Company Name: Shenzhen Weikangming Technology Co., Ltd.
- Publication Date: 2019-08-14
- Product Name: Doppler fetal heart monitor
- Recall Level: Level 3
- Recall Reason: Our company recently discovered that the instruction manual for version V1.0 of our Doppler fetal heart monitor (Registration Certificate No.: Guangdong Food and Drug Administration Medical Device (Approval) No. 20142231098) did not disclose audio output parameter information. This issue is unrelated to product safety and performance and will not cause any adverse effects or harm to users. To ensure compliance with the requirements of Clause 6.8.3 of the national mandatory standard GB9706.9-2008 "Medical Electrical Equipment - Part 2-37: Particular Requirements for Safety of Ultrasonic Diagnostic and Monitoring Equipment", our company has initiated this recall.
- Discovering Company: Shenzhen Weikangming Technology Co., Ltd.
- Manufacturing Company: Shenzhen Weikangming Technology Co., Ltd.
- Summary: Shenzhen Weikangming Technology Co., Ltd. initiated a voluntary Level III recall of its Doppler Fetal Heart Monitors (model FD-200B) on August 13, 2019, reported to the National Medical Products Administration (NMPA). The recall stemmed from a compliance issue where the V1.0 version of the product's instruction manual did not disclose audio output parameter information. This omission, while not affecting product safety, performance, or causing user harm, violated national mandatory standard GB 9706.9-2008, specifically Clause 6.8.3, which outlines safety requirements for medical electrical equipment manuals.
The company's required actions included immediately notifying all affected customers via letters, informing them of the issue and providing the missing audio output parameters. Crucially, this recall did not involve the physical removal of products, allowing existing units to remain in normal use. Corrective measures focused on revising the V1.0 instruction manual to include the necessary sound output parameters. For products already sold, customers received a "Medical Device Recall Notice" and a revised instruction manual page through distributors for manual updates. Any returned products would undergo instruction manual revision, re-inspection, and subsequent re-storage, ensuring regulatory adherence without impacting product utility or user safety.

Company: https://www.globalkeysolutions.net/companies/shenzhen-weikangming-technology-co-ltd/0d8bd3a3-b30b-483c-92db-7b0707798257/