Reported Jul 12, 2017 · Terminated
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed…
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
- Proton Therapy System Product UsageThe Proton Therapy System - Proteus 235 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
- Serial Numbers
PAT.006PAT.108PAT.112PAT.113SAT.116PAT.003
- Serial Numbers
- Amount recalled
- 6 worldwide and 5 in the U.S.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software issue
This product could cause temporary or reversible health problems — stop using it.
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