# China NMPA Product Recall - Radiofrequency tissue coagulation system

Source: https://www.keypedia.com/records/china_product_recall/aesculap-ag/94cb9a69-67be-482d-8e9a-ab7c0c0051da
Source feed: China

> China NMPA product recall for Radiofrequency tissue coagulation system by Aesculap AG published January 13, 2017. Recall level: Level II. B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall fo

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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: Aesculap AG
- Publication Date: 2017-01-13
- Product Name: Radiofrequency tissue coagulation system
- Recall Level: Level II
- Recall Reason: Due to a defective electronic component manufactured by a supplier, some instruments using this component may malfunction in certain situations. The instruments can self-detect the malfunction, displaying an error message and emitting an audible alarm. No patient injury has resulted as a result. Considering the potential risk of prolonged surgery, the manufacturer has decided to initiate a voluntary recall for products with the affected serial numbers.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Aesculap AG
- Summary: B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall for its Radiofrequency Tissue Coagulation System (Model: GN200 RF Transmitter Main Unit). The recall, reported to the National Medical Products Administration (NMPA) in December 2016 and published in January 2017, stems from a defect in an electronic component supplied by a third party. This defect can lead to instrument malfunctions, indicated by error messages and audible alarms, potentially prolonging surgical procedures. While no patient injuries have been reported, the company proactively addressed the risk. The recall affects 72 imported units, with 70 having been sold in China, impacting specific serial numbers globally. As part of the corrective action, B. Braun Medical requires customers to verify and freeze all affected inventory, distribute recall notices, provide replacement instruments, and ensure all recalled products are returned to the manufacturer for proper management.

Company: https://www.keypedia.com/companies/aesculap-ag/59485d99-dc5a-4710-8d68-32cd0df59fe2