Reported Mar 14, 2018 · Terminated
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus…
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, Pencil Beam Scanning version PTS-6.4.11.X The 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
PAT.003 (KR)PAT.006 (US)
- Amount recalled
- 3
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
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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