# China NMPA Product Recall - Microwave ablation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/816f43ac-86c9-4aaf-a4cb-bdab6218a818/
Source feed: China

> China NMPA product recall for Microwave ablation system by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published July 03, 2019. Recall level: Level 3 Recall. On July 3, 2019, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of its microwave ablation system.
- Company Name: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-07-03
- Product Name: Microwave ablation system
- Recall Level: Level 3 Recall
- Recall Reason: Issues include products that do not include all components listed on the registration certificate when sold.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: On July 3, 2019, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its microwave ablation system. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a significant compliance issue. The company identified that the medical device, registered under certificate No. 20173255063, was being distributed and sold without including all components precisely specified on its official registration certificate. This discrepancy is critical as medical devices must strictly adhere to their approved configurations to ensure patient safety and effective performance. The regulatory framework, driven by the NMPA, mandates that all registered medical devices precisely match their certified specifications. Covidien's voluntary recall demonstrates its commitment to rectifying this oversight. As part of the required actions, the company has made available a 'Medical Device Recall Event Report Form,' providing comprehensive details on the specific models, specifications, and batch numbers of the affected products. This allows for efficient identification and removal of the non-compliant devices from the market, safeguarding public health and maintaining trust in medical device integrity.

Company: https://www.globalkeysolutions.net/companies/covidien-medical-devices-international-trading-shanghai-co-ltd/4fdf08b9-af8e-4aed-8993-3e905e973d3b/