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Ion Beam Applications S.A. recalls Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other
Recalled September 15, 2021 · FDA recall Z-2434-2021 · Ion Beam Applications S.A
Hazard
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment · FDA Class II
Units
27 worldwide, 11 in U.S.
Sold at
Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
Description
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Product
Proteus 235- 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 →