# China NMPA Product Recall - MRI-guided radiotherapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-shanghai-medical-devices-co-ltd/b1969178-cbb5-4011-9257-ae8a5d527c1c/
Source feed: China

> China NMPA product recall for MRI-guided radiotherapy system by Elekta (Shanghai) Medical Devices Co., Ltd. published April 23, 2021. Recall level: Level 2. Elekta (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Class II recall of its MRI-gui

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its MRI-guided radiotherapy system.
- Company Name: Elekta (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2021-04-23
- Product Name: MRI-guided radiotherapy system
- Recall Level: Level 2
- Recall Reason: The calculation of the 2D contours used for visual motion monitoring by identifying the magnetic resonance-guided radiotherapy system superimposed on 2D MR projection images may be incorrect.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Summary: Elekta (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Class II recall of its MRI-guided radiotherapy system. This action, publicly reported on April 23, 2021, and further detailed on August 22, 2021, via the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, addresses a critical product deficiency. The primary issue identified is a potential error in the calculation of the 2D contour superimposed on 2D MR projection images, which are essential for visual motion monitoring during radiotherapy. This defect could potentially impact the accuracy and safety of treatment delivery. In response, Elekta (Shanghai) is recalling affected units, with specific models, specifications, and batches detailed in the associated "Medical Device Recall Event Report Form." This proactive measure by Elekta (Shanghai) demonstrates its commitment to patient safety and adherence to regulatory standards under the NMPA's oversight, ensuring medical devices meet necessary performance and safety criteria by remediating the identified issue.

Company: https://www.globalkeysolutions.net/companies/elekta-shanghai-medical-devices-co-ltd/50382c65-250e-4fb4-9df9-cf88c8273214/