# China NMPA Product Recall - Radiofrequency tissue coagulation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-medical-shanghai-international-trading-co-ltd/55af4c22-c9aa-4c58-809f-956c17c077dc/
Source feed: China

> China NMPA product recall for Radiofrequency tissue coagulation system by B. Braun Medical (Shanghai) International Trading Co., Ltd. published July 14, 2017. Recall level: Level 2. On July 14, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls radiofrequency tissue coagulation system
- Company Name: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Radiofrequency tissue coagulation system
- Recall Level: Level 2
- Recall Reason: Due to defects in electronic components, some instruments using these components may malfunction under certain circumstances.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Summary: On July 14, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by B. Braun Medical (Shanghai) International Trading Co., Ltd. The recall pertains to their Radiofrequency Tissue Coagulation System, registered under CFDA Imported Medical Device Registration No. 20143252954. The company reported that the recall was prompted by a defect identified in specific electronic components within the system. This defect could potentially lead to instrument malfunction under certain operating conditions. B. Braun Medical (Shanghai) International Trading Co., Ltd. proactively decided to recall affected units to ensure patient safety and product reliability. Detailed information, including specific models, specifications, and batch numbers of the impacted devices, was made available through an attached 'Medical Device Notice' and 'Medical Device Recall Event Report Form'. This action underscores the company's commitment to compliance with NMPA standards and its responsibility to address product safety concerns promptly.

Company: https://www.globalkeysolutions.net/companies/b-braun-medical-shanghai-international-trading-co-ltd/58112c52-92f6-4aa8-acd6-c5efd892653b/