China NMPA Product Recall - Oncology Information System, a clinical management software for radiotherapy

Elekta Solutions AB, in conjunction with Elekta (Shanghai) Medical Devices Co., Ltd., has initiated a voluntary Level III recall of its Oncology Information System Clinical Management Software. This action, published by the National Medical Products Administration (NMPA) on January 5, 2026, addresses a critical software issue. The main concern is that certain overseas versions of the radiotherapy clinical management software may generate inaccurate dosages following the manual recording of treatment records. The recall specifically targets affected software covered by National Medical Device Registration Certificate No. 20173210587. It is important to note that the products identified in this recall were not imported into China, mitigating direct domestic impact. Elekta has committed to providing specific models, specifications, and further details in a comprehensive "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to patient safety and adherence to regulatory standards under the NMPA framework.