Reported Jul 18, 2018 · Terminated
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam…
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 235Version PTS-11.0.1.2 and PTS-11.0.2
- Product UsageA 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
- Lot codes and dates
- Serial NumbersSAT.122 (EU) SAT.132 (EU) SAT.133 (US)
- Amount recalled
- 3 units
Where it was sold
- Nationwide
- FL
Why it was recalled
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
This product could cause temporary or reversible health problems — stop using it.
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