# China NMPA Product Recall - Fetal/Maternal Monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-mindray-medical-international-co-ltd/c1b043d8-77f6-48b5-9c6a-a87e7b2d9c2b/
Source feed: China

> China NMPA product recall for Fetal/Maternal Monitor by Shenzhen Mindray Medical International Co., Ltd. published July 30, 2021. Recall level: Level 3. Shenzhen Mindray Medical International Co., Ltd. has initiated a voluntary Class 3 recall for 40 uni

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Mindray Medical International Co., Ltd. voluntarily recalls fetal/maternal monitors.
- Company Name: Shenzhen Mindray Medical International Co., Ltd.
- Publication Date: 2021-07-30
- Product Name: Fetal/Maternal Monitor
- Recall Level: Level 3
- Recall Reason: During a recent self-inspection, we discovered that the waterproof rating "IPX2" was missing from the main unit label of the fetal/maternal monitor, which is inconsistent with the registered product technical requirements. In accordance with relevant regulations, our company has initiated a voluntary recall of the affected fetal/maternal monitors. This error does not affect the normal use of the fetal/maternal monitors.
- Discovering Company: Shenzhen Mindray Medical International Co., Ltd.
- Manufacturing Company: Shenzhen Mindray Medical International Co., Ltd.
- Summary: Shenzhen Mindray Medical International Co., Ltd. has initiated a voluntary Class 3 recall for 40 units of its Fetal/Maternal Monitors, specifically models F15 and F15 Air, distributed within China. The recall, reported on July 26, 2021, stems from a recent self-inspection that identified a critical labeling inconsistency: the waterproof rating "IPX2" was missing from the main unit labels. This omission violates the product's registered technical requirements, necessitating corrective action under the National Medical Products Administration (NMPA) regulatory framework. The affected monitors are designed for comprehensive physiological monitoring, including maternal electrocardiogram, heart rate, blood pressure, oxygen saturation, temperature, respiration, uterine contraction, and fetal heart rate and movement. Mindray emphasizes that while the label error is significant for regulatory compliance, it does not impair the monitors' normal function or safety. To rectify the issue, the company is notifying all customers and providing corrected main unit labels for immediate replacement. This swift action ensures adherence to stringent labeling standards and regulatory protocols, demonstrating Mindray's commitment to product integrity and compliance.

Company: https://www.globalkeysolutions.net/companies/shenzhen-mindray-medical-international-co-ltd/934c5d56-5512-4c01-973c-b34eeec6c7d2/