Ion Beam Applications S.A. recalls Proteus 235 proton beam devices with specific versions and serial numbers due to risk of incorrect patient positioning during radiation treatment. Affected units may require correction to prevent treatment errors.
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Ion Beam Applications S.A. recalls specific versions of their Proteus 235 proton beam treatment devices. The recall is due to a risk that correction vectors may be lost if the access point changes after sending the correction, potentially leading to incorrect patient positioning during radiation treatment.
The device may lose correction vector confirmation messages if the access point is changed after sending the correction vector. This can cause the patient to be treated in the wrong position instead of the corrected position, potentially affecting treatment accuracy.
Patients receiving proton beam radiation therapy using the affected Proteus 235 devices are most at risk. Healthcare providers using these devices for cancer treatment may also be affected.
Check for the Proteus 235 device with version numbers PTS-11.0.1.2 or PTS-11.0.2. Affected units have serial numbers SAT.122 (EU), SAT.132 (EU), or SAT.133 (US).
Verify the device version number on the Proteus 235 to see if it matches PTS-11.0.1.2 or PTS-11.0.2.
Check the serial number on the device; affected units have SAT.122 (EU), SAT.132 (EU), or SAT.133 (US).
The correction vector confirmation message may be lost if the access point is changed after sending the correction vector, potentially causing the patient to be treated in the wrong position.
Versions PTS-11.0.1.2 and PTS-11.0.2.
SAT.122 (EU), SAT.132 (EU), and SAT.133 (US).
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-2424-2018 — 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-2424-2018 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.
