# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/2775f99b-754e-4340-a548-ee9c74ba845f/
Source feed: China

> China NMPA product recall for Proton therapy system by Ion Beam Applications S.A. published November 29, 2017. Recall level: Level 2 Recall. On November 29, 2017, the National Medical Products Administration (NMPA) published a Level II proac

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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: 2017-11-29
- Product Name: Proton therapy system
- Recall Level: Level 2 Recall
- Recall Reason: When creating/importing multiple isocenter treatment plans, the proton therapy system does not check whether the difference between different center positions in the patient positioning system is consistent with the difference between different isocenter positions in the treatment plan. If the positioning is incorrect, the user will not receive a notification, and there is a risk of treatment deviation.
- Discovering Company: Ebia (Beijing) Particle Accelerator Technology Co., Ltd.
- Manufacturing Company: Ion Beam Applications S.A.
- Summary: On November 29, 2017, the National Medical Products Administration (NMPA) published a Level II proactive recall initiated by Ion Beam Applications S.A. (IBA) for its Proton Therapy Systems (Registration No. 国药管械（进）2003第3320636号). The recall addresses a critical safety concern regarding patient positioning during multi-isocenter treatment plans. The primary issue identified is that the proton therapy system fails to automatically verify the consistency between manually entered center locations in the patient positioning system and the isocenter locations specified in the treatment plan. This means users are not alerted if there's a discrepancy between these crucial coordinates. Consequently, if the patient positioning system's center location is incorrectly entered and the user does not perform manual verification with X-ray imaging, as recommended in IBA's Clinical User Guide, there is a risk of patient positioning errors. To mitigate this, IBA is undertaking several required actions. The company is distributing an "Emergency Field Safety Notice" to affected customers in China. This notice instructs users to diligently ensure that the differences in center positions entered into the patient positioning system match the corresponding differences in isocenter positions from the treatment plan. Furthermore, IBA will implement a software enhancement to automatically perform this consistency check. Should any mismatch be detected by the system, it will generate a warning notification for the user, thereby enhancing patient safety and treatment accuracy across affected regions including the USA, China, South Korea, France, Germany, Italy, Sweden, Netherlands, Czech Republic, and Poland.

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