Ion Beam Applications recalls Proteus 235 proton therapy systems due to risk of improper accessory insertion causing system operation without proper safety. Affected units may need verification and action.
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Ion Beam Applications is recalling their Proteus 235 proton therapy systems because an accessory can be inserted incorrectly, allowing the system to operate without proper safety. This could lead to unsafe treatment conditions if the system is used without correct configuration.
The system can operate with an accessory improperly inserted, meaning it might deliver radiation treatment without proper safety checks. This could lead to incorrect radiation doses or treatment errors for patients.
Patients receiving proton therapy using the Proteus 235 system are most at risk. Healthcare facilities that use this device for medical treatments may also be affected.
Check for the Proteus 235 model name on the device or its packaging. The system may be sold under brand names Proteus Plus or Proteus ONE. This recall applies to medical devices used in proton therapy treatments.
Check the device label for the model name, which may be Proteus 235, Proteus Plus, or Proteus ONE.
The recall is due to a risk that an accessory can be improperly inserted, allowing the proton therapy system to operate without proper safety checks.
Check the device label for the model name. If it matches Proteus 235, Proteus Plus, or Proteus ONE, you may need to contact the manufacturer for further instructions.
The recall states that improper accessory insertion could lead to unsafe treatment conditions, but the official notice does not specify a risk of serious injury in normal use.
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-0934-2018 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-0934-2018 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.
