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Ion Beam Applications S.A. recalls Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients
Recalled June 20, 2018 · FDA recall Z-2173-2018 · Ion Beam Applications S.A
Hazard
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. · FDA Class II
Units
19 units
Sold at
Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
Description
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Product
Proteus 235 The PTS is a medical 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →