Reported May 2, 2018 · Terminated
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with…
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin du Cyclotron, 3 · Louvain La Neuve, N/A · N/A
Is this the product you have?
- Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Lot codes and dates
- Affected versionPTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)
- Amount recalled
- 5
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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