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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