Home / Recalls / Medical Devices
Ion Beam Applications S.A. recalls Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton be
Recalled July 18, 2018 · FDA recall Z-2424-2018 · Ion Beam Applications S.A
Hazard
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. · FDA Class II
Units
3 units
Sold at
Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Description
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.
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.
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →