Ion Beam Applications S.A. recalls Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product
Recalled Product
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 for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Hazard / Issue
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.
Issued by
FDA
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