# China NMPA Product Recall - Radiotherapy planning software

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-shanghai-medical-devices-co-ltd/594058b8-5702-4fe4-8ce8-45f946a066a5/
Source feed: China

> China NMPA product recall for Radiotherapy planning software by Elekta (Shanghai) Medical Devices Co., Ltd. published September 22, 2021. Recall level: Level 3. Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its imported r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary recall of its radiotherapy planning software.
- Company Name: Elekta (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2021-09-22
- Product Name: Radiotherapy planning software
- Recall Level: Level 3
- Recall Reason: Elekta discovered that when customers operate the system according to their specific usage needs, contour edits may be saved to unplanned image sets, which may further lead to differences between the output of the initial reference plan and the updated plan.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Summary: Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its imported radiotherapy planning software, publicly announced by the National Medical Products Administration (NMPA) on September 22, 2021. The recall addresses a critical issue where, under specific user operational conditions, contour edits within the software could be erroneously saved to non-planned image sets. This defect poses a risk by potentially causing discrepancies between the initial reference treatment plan and the updated plan output for patients undergoing radiotherapy. The company proactively identified this concern and issued a global field safety notice for its software, which is an integral component of MRI-guided radiotherapy systems. In response, Elekta (Shanghai) Medical Devices Co., Ltd. is implementing on-site corrective actions for all affected products worldwide, demonstrating compliance with regulatory standards and a commitment to patient safety within the medical device industry.

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