Ion Beam Applications recalls PROTEUS 23:5 proton therapy systems with C230 accelerator control units that may cause irradiation if critical parameters are outside tolerances. Affected units have specific serial numbers and versions.
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Ion Beam Applications is recalling its PROTEUS 235 proton therapy systems due to a risk that irradiation could continue even when critical accelerator control parameters are outside safe limits. This could potentially expose patients to unnecessary radiation during treatment.
The system's C230 accelerator control unit may not properly stop irradiation when certain critical parameters go outside safe limits. This could lead to unintended radiation exposure during treatment sessions.
Patients receiving proton therapy using the PROTEUS 235 system with specific serial numbers and versions are most at risk. Healthcare facilities that use this equipment may also be affected.
Check for serial numbers starting with SAT136 or SAT140, and versions from PTS-11.1 and PTS-12. The system was sold with specific UDI codes and dates.
Identify if your PROTEUS 235 system has serial numbers starting with SAT136 or SAT140 and versions from PTS-11.1 or PTS-12.
The C230 accelerator control unit may not stop irradiation when critical parameters go outside safe limits, potentially causing unintended radiation exposure during treatment.
Check for serial numbers starting with SAT136 or SAT140, and versions from PTS-11.1 or PTS-12. The system was sold with specific UDI codes and dates.
The recall record does not specify a remedy, so contact Ion Beam Applications directly for guidance.
We’ve drafted a message you can send Ion Beam Applications to request your refund or repair — edit it as you like.
Subject: Recall Z-1945-2024 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-1945-2024 from Ion Beam Applications. 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.
