Ion Beam Applications recalls Proteus 235 proton therapy devices due to risk of patient or user injury from improper nozzle alignment during treatment. Affected units may cause crushing or mistreatment if apertures aren't correctly positioned.
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
Ion Beam Applications is recalling its Proteus 235 proton therapy devices because improper alignment of the nozzle components can cause injury to patients or users. This risk occurs when the apertures or accessories aren't correctly positioned in the snout 300x400 or snout XL models.
The device can cause injury if the apertures or accessories aren't correctly positioned in the snout 300x400 or snout XL. This misalignment may lead to crushing injuries for the patient or user, and could result in mistreatment of the patient during radiation therapy.
Patients and medical professionals using the Proteus 235 proton therapy devices for cancer treatment are most at risk. The specific models affected include the Universal Nozzle with snout 300x400 and PBS dedicated nozzle with snout XL.
Check for the Proteus 235 model with either the Universal Nozzle and snout 300x400 or PBS dedicated nozzle with snout XL. These devices were sold with the specified patents listed in the recall notice.
Ensure apertures and accessories are correctly positioned in the snout 300x400 or snout XL before use.
The Proteus 235 with Universal Nozzle and snout 300x400, or PBS dedicated nozzle with snout XL.
Improper alignment of apertures or accessories can cause crushing injuries to patients or users, and risk mistreatment during radiation therapy.
The recall record does not specify a remedy or fix for this issue.
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-2470-2018 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-2470-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
