# China NMPA Product Recall - Proton therapy system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ion-beam-applications-sa/d7516c18-40bd-47a4-b8d5-9820a3155661/
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. (IBA) initiated a Class II voluntary recall of its Proteus 235 proton the

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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 if the nozzle is not properly locked, the rotating gantry of the proton therapy system may still rotate. Metal shavings generated on the inner wall of the recess may block the limit switch from resetting and keeping it in the closed state. This can cause the positioning management system to mistakenly determine that the pin is in place, thus allowing the gantry to rotate. Consequently, 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 of its Proteus 235 proton therapy systems, as detailed in a National Medical Products Administration (NMPA) document published on April 21, 2017, following a report dated March 22, 2017. The recall, reported by IBA's Chinese entity, Ion Beam (Beijing) Particle Accelerator Technology Co., Ltd., addresses a critical safety concern. The primary issue is that the system's rotating gantry may operate even when the treatment nozzle is not securely locked. This dangerous malfunction stems from metal shavings accumulating within the nozzle locking mechanism, preventing a crucial limit switch from resetting. Consequently, the system's positioning management misinterprets an unlocked nozzle as secured, allowing gantry rotation. This defect has led to instances of nozzle detachment when the gantry rotated to 90° and 270°, posing significant patient safety risks. Under the NMPA regulatory framework, IBA has outlined immediate and long-term corrective actions. Temporary measures include issuing a "Field Safety Notice" to all affected customers, advising manual verification of nozzle locking before gantry rotation, and instructing service teams to inspect and clean limit switches while adding visual verification markers. For a long-term resolution, IBA plans to update maintenance protocols to incorporate annual verification of the nozzle holder locking mechanism, ensuring enhanced patient safety and system reliability.

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