Ion Beam Applications recalls Proteus 235, ProteusPLUS, and Proteus ONE proton therapy devices with PTS-7.X.X or PTS-8.X.X software versions. Switching treatment modes may cause under-irradiation or delayed patient treatment with extra X-ray exposure.
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
Ion Beam Applications recalls three proton therapy devices that could cause under-treatment or delayed patient care if users switch between specific treatment modes. This affects patients receiving radiation therapy for tumors.
When switching from Pencil Beam Scanning to Uniform Scanning treatment modes, the device may miscalculate radiation settings. If users ignore error messages, patients could receive less radiation than intended. Rebooting the system might delay treatment and require additional X-ray exposure.
Patients receiving proton therapy for tumors or other radiation-sensitive conditions. Those using the affected device versions (PTS-7.X.X or PTS-8.X.X) are most at risk.
Check for software versions PTS-7.X.X or PTS-8.X.X. Affected devices include Proteus 235, ProteusPLUS, and Proteus ONE with serial numbers PAT.107 (EU), PAT.108, PAT.112, PAT.113, PAT.116 (US).
Verify your device has PTS-7.X.X or PTS-8.X.X software versions to determine if it's affected.
If an error message appears when switching treatment modes, do not resume treatment without analyzing the cause.
If the error message persists, reboot the Scanning Magnets Power Supply Electronic Unit to avoid treatment delays.
Proteus 235, ProteusPLUS, and Proteus ONE devices with software versions PTS-7.X.X or PTS-8.X.X, including serial numbers PAT.107 (EU), PAT.108, PAT.112, PAT.113, PAT.116 (US).
The patient may receive less radiation than intended, leading to under-irradiation.
This may cause a delay in treatment and require re-alignment, potentially adding an extra X-ray dose to the patient.
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-1477-2018 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-1477-2018 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.
