Ion Beam Applications recalls Proteus 235-Proton Therapy Systems with specific serial numbers due to risk of incorrect radiation delivery if trigger input is forgotten during treatment. Affected units include PAT.107 through SAT.133 across multiple regions.
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Ion Beam Applications is recalling specific models of their Proteus 235-Proton Therapy System. If users forget to manually select the trigger input during beam gating, the treatment may be delivered incorrectly, potentially causing harmful radiation exposure to the patient.
The system requires manual trigger input to activate beam gating during treatment. If this step is skipped, the radiation beam may be delivered without proper positioning, risking incorrect treatment delivery to the patient.
Patients receiving proton therapy using the affected Proteus 235 systems are most at risk. Healthcare providers who operate these systems with the recalled serial numbers should verify their equipment.
Check the serial number on your Proteus 235-Proton Therapy System. Affected units include PAT.107 (EU), PAT.108 (US), PAT.109 (US), and other specific serial numbers listed in the recall notice.
Identify your system's serial number to determine if it is in the affected list: PAT.107 (EU), PAT.108 (US), PAT.109 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
If the user forgets to manually select the trigger input during beam gating, the proton irradiation may be delivered without proper positioning, potentially causing incorrect treatment delivery to the patient.
Check the serial number on your Proteus 235-Proton Therapy System. Affected units include PAT.107 (EU), PAT.108 (US), PAT.109 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), and SAT.133 (US).
No action is required if your system's serial number is not listed in the affected units.
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-2155-2021 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-2155-2021 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.
