Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to inability to load treatment plans after abortion. Affected units have specific serial numbers from May 2019 (US) and October 2019 (EU).
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Ion Beam Applications S.A. is recalling their Proteus 235 proton therapy systems because they can't properly load treatment plans after an abortion. This could lead to incomplete radiation treatments for patients. The recall affects specific units with serial numbers from May 2019 (US) and October 2019 (EU).
The system may not be able to resume aborted irradiations because treatment plans cannot be loaded. This could result in incomplete radiation treatments for patients who require ongoing therapy. The hazard is specific to the system's ability to handle treatment plan resumption after interruptions.
Patients receiving proton therapy at medical facilities using the Proteus 235 system are most at risk. The recall applies to specific units manufactured in the US and EU between May 2019 and October 2019.
Check for serial numbers starting with SAT.140 (US) manufactured in May 2019 or SBF.112 (EU) manufactured in October 2019. The product is a medical device used for proton therapy treatments.
Look for serial numbers starting with SAT.140 (US) manufactured in May 2019 or SBF.112 (EU) manufactured in October 2019.
The Proteus 235 is a medical device designed to produce and deliver proton beams for treating patients with localized tumors and other radiation-sensitive conditions.
The system may not be able to resume aborted irradiations because treatment plans cannot be loaded after interruptions.
Check for serial numbers starting with SAT.140 (US) manufactured in May 2019 or SBF.112 (EU) manufactured in October 2019.
We’ve drafted a message you can send Ion Beam Applications S.A. to request your refund or repair — edit it as you like.
Subject: Recall Z-2715-2020 — Ion Beam Applications S.A. Ion Beam Applications S.A. Hello, I own a Ion Beam Applications S.A. that is covered by recall Z-2715-2020 from Ion Beam Applications S.A.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
