# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/126aa067-e489-4cf0-b0b7-32480c72f9aa/
Source feed: China

> China NMPA product recall for Proton therapy system by Ion Beam Applications S.A. published May 02, 2017. Recall level: Level 2 Recall. Ion Beam Applications S.A., through its Chinese unit Ion Beam (Beijing) Particle Accelerator Technol

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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: 2017-05-02
- Product Name: Proton therapy system
- Recall Level: Level 2 Recall
- 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 (see Appendix 1). Metal shavings generated on the inner wall of the recess may prevent the limit switch from resetting and closing, thus preventing the locating pin from actually functioning. The limit switch signal from the positioning management system is misinterpreted 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: Ion Beam Applications S.A., through its Chinese unit Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., initiated a Class II voluntary recall for its Proteus 235 Proton Therapy System. This action, reported to the National Medical Products Administration (NMPA) on March 22, 2017, addressed a critical safety concern where the system's rotating gantry could operate even when the nozzle was not properly secured. The root cause was identified as metal shavings accumulating within the nozzle's locking mechanism, which prevented the limit switch from resetting. This led the position management system to falsely register the nozzle as locked, resulting in nozzle detachment when the gantry rotated to 90° and 270°.

Immediate corrective actions included notifying affected customers in China via 

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