# China NMPA Product Recall - Color Doppler ultrasound system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-mindray-bio-medical-electronics-co-ltd/2b539bfa-fe2f-4312-998d-1e8cd43e9d74/
Source feed: China

> China NMPA product recall for Color Doppler ultrasound system by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. published September 11, 2020. Recall level: Level 3. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has initiated a voluntary Class III recall for it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. voluntarily recalls color Doppler ultrasound systems.
- Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Publication Date: 2020-09-11
- Product Name: Color Doppler ultrasound system
- Recall Level: Level 3
- Recall Reason: Some magnetic field generators have durability issues, which may cause inaccurate positioning during the use of the product's fusion imaging function.
- Discovering Company: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Manufacturing Company: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Summary: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has initiated a voluntary Class III recall for its color Doppler ultrasound systems following the identification of a significant functional issue. The company's supplier, Northern Digital Inc., alerted Mindray to potential durability problems affecting specific mid-range transmitters. These transmitters are crucial components, providing essential probe navigation and positioning capabilities for the fusion imaging function within Mindray's Resona series ultrasound products. The identified defect carries the risk of leading to inaccurate positioning during the utilization of this specialized imaging function, which is critical for precise medical diagnostics and effective patient care. This proactive measure is being undertaken voluntarily by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and falls under the regulatory oversight of the National Medical Products Administration (NMPA). The company is actively recalling all affected manufactured systems to mitigate any potential risks. Comprehensive details regarding the specific product models, technical specifications, and batch numbers impacted by this recall are formally documented and available in the company's "Medical Device Notification Form" and the "Recall Incident Report Form." This decisive action underscores Mindray's commitment to upholding product reliability and ensuring patient safety standards.

Company: https://www.globalkeysolutions.net/companies/shenzhen-mindray-bio-medical-electronics-co-ltd/f6d8536c-c1ec-4b07-a495-a1aa8ac9d9db/