FDA-Device2018-06-20Class II
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.
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.
Sold states
Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
Affected count
19 units
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2018Don't want to check this manually?
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