# China NMPA Product Recall - Oncology Information System for Clinical Management of Radiation Therapy

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-solutions-ab/777e946a-a8d5-45c8-a155-6c8a37a29957/
Source feed: China

> China NMPA product recall for Oncology Information System for Clinical Management of Radiation Therapy by Elekta Solutions AB published February 21, 2025. Recall level: Level 3 Recall. Elekta Solutions AB, a prominent medical device manufacturer, has initiated a voluntary recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta Solutions AB has initiated a voluntary recall of its radiotherapy clinical management software.
- Company Name: Elekta Solutions AB
- Publication Date: 2025-02-21
- Product Name: Oncology Information System for Clinical Management of Radiation Therapy
- Recall Level: Level 3 Recall
- Recall Reason: There are errors in the displacement deviation calculation.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta Solutions AB
- Summary: Elekta Solutions AB, a prominent medical device manufacturer, has initiated a voluntary recall of its Radiotherapy Clinical Management Software, specifically identified as the Oncology Information System (National Medical Device Registration Certificate 20173210587). This action, reported by Elekta (Shanghai) Medical Devices Co., Ltd. on February 21, 2025, stems from discovered errors in the software's displacement deviation calculation. Such inaccuracies in critical medical software could potentially impact the precision of patient treatment in radiotherapy, highlighting the importance of this corrective measure.

The recall has been designated as Level III by the National Medical Products Administration (NMPA), the primary regulatory authority overseeing medical devices in China. While the specific details regarding affected models, specifications, and batches are outlined in an accompanying Medical Device Recall Event Report Form, the NMPA document explicitly states that the implicated products were not imported into China. This suggests a proactive global quality control measure, even if the direct market impact within China is limited. The recall is a manufacturer-initiated action, indicating a self-identification of the issue rather than an external inspection finding. This proactive approach by Elekta Solutions AB demonstrates adherence to stringent quality management systems and a commitment to patient safety within the highly regulated medical device sector.

Company: https://www.globalkeysolutions.net/companies/elekta-solutions-ab/f8686f22-2a68-4a2f-9a90-36f4e8411bff/