# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/d747150c-af2a-4442-94e1-12ece54ddd0b/
Source feed: China

> China NMPA product recall for Proton therapy system by Ion Beam Applications S.A. published April 21, 2017. Recall level: Level 2 Recall. Ion Beam Applications S.A., in conjunction with its Chinese affiliate, Ion Beam (Beijing) Particle A

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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: 2017-04-21
- 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. 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: Ion Beam Applications S.A., in conjunction with its Chinese affiliate, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., initiated a Class II voluntary recall of its Proton Therapy System, as published by the National Medical Products Administration (NMPA) on April 21, 2017. The recall addresses a significant safety concern where the system's rotating gantry could activate even when the treatment nozzle was not securely fastened. The root cause was identified as metal shavings accumulating near a limit switch in the nozzle's locking mechanism. This obstruction prevented the switch from resetting correctly, causing the system to erroneously interpret the nozzle as locked. This malfunction led to instances of nozzle detachment during gantry rotation at 90° and 270°. As immediate corrective measures, all affected customers in China received a "Field Safety Notice." Users are advised to visually confirm the nozzle is securely locked before initiating gantry rotation. Additionally, IBA's customer service teams are inspecting and cleaning limit switch locking rings, removing metal filings, and affixing visual markers for verification. For a long-term solution, Ion Beam Applications S.A. plans to update maintenance schedules to include annual verification of the nozzle holder locking mechanism.

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