# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/451cff5d-df65-4e9b-9d5b-5c6d5aadba34/
Source feed: China

> China NMPA product recall for Proton therapy system by Ion Beam Applications S.A. published March 31, 2017. Recall level: Level 2. On March 31, 2017, the National Medical Products Administration (NMPA) announced a Class II voluntar

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ion Beam Applications S.A. proactively recalls proton therapy systems.
- Company Name: Ion Beam Applications S.A.
- Publication Date: 2017-03-31
- Product Name: Proton therapy system
- Recall Level: Level 2
- Recall Reason: Even when the nozzle is not properly locked, the rotating gantry of the proton therapy system may still rotate. The nozzle is secured to the nozzle holder by a rotating collar, which is positioned by a locating pin. When the locating pin is inserted, it triggers a limit switch. Metal shavings generated on the inner wall of the recess may prevent the limit switch from resetting and closing, thus disabling the locating pin. The positioning management system misinterprets the limit switch signal as the locating pin being in place (the nozzle being locked), allowing the gantry to rotate. As a result, the nozzle may detach when the gantry rotates to 90° and 270°.
- Discovering Company: Ebia (Beijing) Particle Accelerator Technology Co., Ltd.
- Manufacturing Company: Ion Beam Applications S.A.
- Summary: On March 31, 2017, the National Medical Products Administration (NMPA) announced a Class II voluntary recall by Ion Beam Applications S.A. for its proton therapy systems. Initiated by its Chinese entity, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., the recall addresses a critical safety defect. The primary issue is that the system's rotating gantry may operate when the treatment nozzle is not securely locked. This malfunction occurs because metal shavings can accumulate near a limit switch, preventing it from resetting properly. Consequently, the positioning management system misinterprets the nozzle as being locked, potentially leading to the nozzle detaching when the gantry rotates to 90° or 270°.

In response, Ion Beam Applications S.A. has implemented immediate and long-term corrective measures. Temporarily, all affected customers in regions including China, the United States, and South Korea were notified via a "Field Safety Notice," advising manual verification of nozzle locking before gantry rotation. Additionally, IBA service teams were instructed to inspect and clean the limit switch area and install visual verification markers. For a permanent solution, the company plans to update its maintenance protocols to include annual verification of the nozzle holder locking mechanism, ensuring enhanced patient safety and device integrity.

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