# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/ccf83bf0-8dd1-43a6-8284-20c87dd94eaf/
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. Ion Beam Applications S.A. (IBA) initiated a Class II voluntary recall for its Proton Therapy System

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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: Ion Beam Applications S.A. (IBA) initiated a Class II voluntary recall for its Proton Therapy System, specifically the Proteus 235 model. This recall, reported on March 22, 2017, and published by the National Medical Products Administration (NMPA) on March 31, 2017, addresses a significant safety concern. The primary issue involves the rotating gantry of the proton therapy system, which could rotate even when the treatment nozzle was not properly secured. This critical defect stemmed from metal shavings accumulating on the inner wall of the recess, preventing a crucial limit switch from resetting. Consequently, the positioning management system misinterpreted the switch signal, falsely indicating the nozzle was locked. This malfunction presented a risk of the nozzle detaching when the gantry rotated to 90° and 270°. The affected products were distributed in several countries, including the United States, South Korea, France, Germany, and China. In response, IBA implemented both immediate and long-term corrective actions. Immediately, all affected customers received a "Field Safety Notice," advising users to manually verify the nozzle's secure locking before initiating gantry rotation. IBA's customer service teams were also dispatched to inspect limit switch locking rings, remove obstructing metal filings, and affix visual markers for easier verification. For a long-term resolution, IBA committed to updating its maintenance plan to incorporate annual verification of the nozzle holder locking mechanism.

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