# China NMPA Product Recall - Tumor Information Management System

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-inc-usa/6801b58d-f243-4e0e-a6b2-49a208c7b7d5/
Source feed: China

> China NMPA product recall for Tumor Information Management System by Elekta, Inc. (USA) published November 18, 2019. Recall level: Level 3 Recall. Elekta, Inc. initiated a Class III voluntary recall of its Tumor Information Management System (MOSA

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta, Inc. proactively recalled its tumor information management system.
- Company Name: Elekta, Inc. (USA)
- Publication Date: 2019-11-18
- Product Name: Tumor Information Management System
- Recall Level: Level 3 Recall
- Recall Reason: Users may enter height and weight in metric units when recording vital signs data, without realizing that the system defaults to US standard units and without switching the system unit option. This risk may result in the patient's body surface volume (BSA) being much higher than expected. If this situation is not detected, the patient may receive a higher dose of chemotherapy drugs based on body surface volume than required.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta, Inc. (USA)
- Summary: Elekta, Inc. initiated a Class III voluntary recall of its Tumor Information Management System (MOSAIQ Oncology Information System), as reported to the National Medical Products Administration (NMPA) on November 18, 2019. The recall, stemming from a report on October 17, 2019, addresses a critical software issue where users might inadvertently enter vital sign data (height and weight) in metric units while the system defaults to US standard units. This discrepancy could lead to an incorrect and significantly overstated calculation of a patient's body surface area (BSA), potentially resulting in patients receiving a higher dose of chemotherapy than medically required. Elekta (Shanghai) Medical Device Co., Ltd. serves as the agent for this recalling unit. While this is a global recall, the associated risk does not affect products sold or installed in China. This is because the MOSAIQ chemotherapy module is not registered in China, and the specific process of entering patient height and weight that triggers this software issue is not applicable in Chinese clinical settings. Consequently, no specific actions are required for users within China. The recall aims to mitigate potential patient harm stemming from incorrect chemotherapy dosages due to miscalculated BSA in other affected regions globally.

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