Reported Jun 8, 2022 · Ongoing

Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized…

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. · 3 Chemin Du Cyclotron · Louvain-la-neuve, N/A · N/A

Is this the product you have?

  • Proteus235- Proton Therapy Systemto produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Lot codes and dates
  • UDI-DI(01)05404013801138
  • Serial Numbers
    • PAT108 (US)
    • PAT112 (US)
    • SAT116 (US). PAT107 (EU)
Amount recalled
4 units

Where it was sold

Why it was recalled

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

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