# China NMPA Product Recall - Radiotherapy patient positioning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medical-intelligence-medizintechnik-gmbh/0834518a-7c24-4739-9475-cd866df871e8/
Source feed: China

> China NMPA product recall for Radiotherapy patient positioning system by Medical Intelligence Medizintechnik GmbH published September 19, 2019. Recall level: Level 2 Recall. On September 19, 2019, the National Medical Products Administration (NMPA) announced a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medical Intelligence Medizintechnik GmbH is proactively recalling its radiotherapy patient positioning system.
- Company Name: Medical Intelligence Medizintechnik GmbH
- Publication Date: 2019-09-19
- Product Name: Radiotherapy patient positioning system
- Recall Level: Level 2 Recall
- Recall Reason: The products in question may have issues with different decimal separator settings in different countries, which could affect the system.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Medical Intelligence Medizintechnik GmbH
- Summary: On September 19, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Medical Intelligence Medizintechnik GmbH. The recall, reported by Elekta (Shanghai) Medical Device Co., Ltd., pertains to the company's radiotherapy patient positioning system, registered under certificate number 20173311406. The primary issue prompting this action is a potential system malfunction stemming from inconsistencies in decimal separator settings across different countries. This discrepancy could impact the system's operational accuracy, posing a risk to patient safety. As a required action under NMPA's regulatory framework, Medical Intelligence Medizintechnik GmbH is voluntarily recalling affected models, specifications, and batches of the radiotherapy patient positioning system. The Class II designation signifies that the product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Further details regarding the specific products involved are available in the accompanying recall event report. This recall highlights the importance of stringent software localization and robust quality control in medical device manufacturing to ensure consistent performance and patient well-being across diverse international markets.

Company: https://www.globalkeysolutions.net/companies/medical-intelligence-medizintechnik-gmbh/2aa74925-34b3-45a9-bcdc-def8699ea3ed/