# China NMPA Product Recall - Radiation Treatment Planning System

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-inc-usa/3202c391-de30-4301-961a-9ee8dc34df43/
Source feed: China

> China NMPA product recall for Radiation Treatment Planning System by Elekta, Inc. (USA) published August 06, 2021. Recall level: Level 3 Recall. Elekta, Inc. (USA), in conjunction with Elekta (Shanghai) Medical Device Co., Ltd., has initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta, Inc. (USA) has initiated a voluntary recall of its Radiation Treatment Planning System software.
- Company Name: Elekta, Inc. (USA)
- Publication Date: 2021-08-06
- Product Name: Radiation Treatment Planning System
- Recall Level: Level 3 Recall
- Recall Reason: Early versions of the product may experience computational issues in specific use cases.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta, Inc. (USA)
- Summary: Elekta, Inc. (USA), in conjunction with Elekta (Shanghai) Medical Device Co., Ltd., has initiated a voluntary Class III recall of its Radiation Treatment Planning Software (Registration Certificate No.: 20153210147). The recall was reported on August 6, 2021. The primary issue identified is that specific early versions of the software may exhibit calculation problems under certain usage scenarios, potentially affecting treatment planning accuracy. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. As a required action, the company is recalling affected product models and batches to mitigate potential risks associated with the identified software anomaly. Detailed information regarding the affected products is available in the “Medical Device Recall Event Report Form” provided by Elekta, Inc. (USA). This proactive measure ensures patient safety and the reliability of medical devices used in radiation therapy.

Company: https://www.globalkeysolutions.net/companies/elekta-inc-usa/db629d27-a675-4012-ac33-f917646156a5/