Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to potential range variability in radiation treatment planning. This may affect treatment accuracy for patients with localized tumors.
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
Ion Beam Applications S.A. is recalling their Proteus 235 proton therapy systems because the radiation range could vary depending on whether the layer is the first layer of the treatment plan. This could lead to inaccurate radiation delivery during cancer treatments.
The system's radiation range might differ based on whether the treatment layer is the first layer in the irradiation plan. This could cause the radiation to target the wrong area, potentially affecting treatment effectiveness or safety for patients.
Patients receiving proton therapy for localized tumors may be affected. Medical professionals using the Proteus 235 system are most at risk of treatment inaccuracies.
The Proteus 235 system with Pencil Beam Scanning version PTS-6.4.11.X is a medical device for proton therapy. It may be marketed under brand names Proteus Plus or Proteus ONE.
Identify if your device has the Proteus 235 model with Pencil Beam Scanning version PTS-6.4.11.X or brand names Proteus Plus or Proteus ONE.
The recall is due to potential range variability in radiation treatment planning, which could affect treatment accuracy for patients with localized tumors.
The official notice does not specify the risk level or potential injuries. The hazard is described as a possible variation in radiation range, but the exact impact on patient safety is not detailed.
Check if your device is the Proteus 235 with Pencil Beam Scanning version PTS-6.4.11.X or brand names Proteus Plus or Proteus ONE.
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-0931-2018 — 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-0931-2018 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.
