# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/9275d2c2-8e10-4519-a36c-42cd5f3f05f3/
Source feed: China

> China NMPA product recall for Proton therapy system by Ion Beam Applications S.A. published November 28, 2017. Recall level: Level 2. Ion Beam Applications S.A. initiated a proactive, voluntary Class II recall of its proton therapy sy

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ion Beam Applications S.A. actively recalls proton therapy systems.
- Company Name: Ion Beam Applications S.A.
- Publication Date: 2017-11-28
- Product Name: Proton therapy system
- Recall Level: Level 2
- Recall Reason: When creating/importing treatment plans with multiple isocenters, the proton therapy system does not check the differences between different isocenter locations in the patient positioning system and the differences between different isocenter locations in the actual treatment plan. If the isocenter location in the patient positioning system of the prescription is incorrect, the user will not be notified, and the system will not check the consistency between these locations and the isocenter locations in the treatment plan, which may result in any offset.
- Discovering Company: Ebia (Beijing) Particle Accelerator Technology Co., Ltd.
- Manufacturing Company: Ion Beam Applications S.A.
- Summary: Ion Beam Applications S.A. initiated a proactive, voluntary Class II recall of its proton therapy systems, as announced by the National Medical Products Administration (NMPA) on November 28, 2017. The recall addresses a critical safety concern regarding the system's handling of treatment plans involving multiple isocenters. The primary issue is the system's failure to automatically verify the consistency between manually entered center locations in the patient positioning system and the isocenter locations specified in the treatment plan. Users are required to manually input these differing center locations, but the system does not perform a check to ensure that the positional differences in the patient positioning system match those in the treatment plan. Consequently, if an incorrect center location is entered from the prescription, the system provides no notification to the user. This deficiency creates a risk of patient misalignment during proton therapy, especially when treating with multiple isocenters, unless users diligently follow the company's Clinical User Guide. This guide recommends manual verification of patient placement for each radiation field using X-ray images. The recall aims to mitigate potential deviations that could arise from this lack of automated cross-verification, ensuring patient safety within the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/ion-beam-applications-sa/2971013a-2c8f-4400-bfa7-ff178c12abf8/