Proteus 235-Proton Therapy System May Deliver Unintended Radiation
The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm medical device with no reported injuries or illnesses. The recall addresses a potential for incorrect radiation delivery due to beam gating omission, creating risk of mispositioned treatment fields, but no adverse events have been documented.
Plain-English summary
The Proteus 235-Proton Therapy System is a medical device used to deliver targeted proton therapy. It can be configured to use beam gating, a safety mechanism that restricts when radiation is delivered during treatment.
If a treatment operator forgets to manually select the trigger input when beam gating has been prescribed, the system will deliver proton radiation without the prescribed gating. When the beam is not gated as intended, the treatment field may be positioned incorrectly, potentially causing radiation to reach unintended areas.
Hospitals and treatment centers using this system should review their treatment protocols to ensure beam gating selection is confirmed when prescribed. Safety procedures should include verification steps to ensure that beam gating is properly activated before treatment begins.
The recalled product
- Product
- Proteus 235-Proton Therapy System
- Manufacturer
- Ion Beam Applications S.A.
- Category
- Medical Device — Proton Therapy
- Hazard
- treatment-positioning-error
- beam-gating-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Serial Numbers: PAT.107 (EU)
- PAT.108 (US)
- PAT.109 (US)
- PAT.115 (EU)
- 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).
Distribution
Distributed in 5 states:
- FL
- PA
- TN
- TX
- VA
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