Reported Jan 16, 2019 · Terminated
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a…
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
Is this the product you have?
- Proteus 235 Product UsageThe Proton Therapy
- System - Proteus 235 (brand namesProteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck
- Lot codes and dates
SAT.123SBF.101SBF.103SBF.104SBF.105SBF.107SBF.109
- Amount recalled
- 7
Where it was sold
Why it was recalled
There is a risk of detachment of the Compact Gantry Rolling Floor.
This product could cause temporary or reversible health problems — stop using it.
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