Reported Mar 21, 2018 · Terminated
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of…
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, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Lot codes and dates
PAT.000 (US)PAT.001 (CN)PAT.003 (KR)PAT.006 (US)PAT.107 (EU)PAT.108 (US)PAT.109 (US)PAT.110 (US)PAT.111 (EU)PAT.112 (US)PAT.113 (US)PAT.114 (EU)PAT.115 (EU)SAT.116 (US)SAT.117 (EU)SAT.119 (US)SAT.120 (EU)SAT.122 (EU)SAT.123 (US)SAT.126 (US)SAT.132 (EU)SAT.133 (US)SBF.101 (EU)SBF.105 (US)
- Amount recalled
- 37
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
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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