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Ion Beam Applications S.A. recalls Proteus 235 and Proteus ONE proton therapy systems
Recalled July 12, 2017 · FDA recall Z-2672-2017 · Ion Beam Applications S.A
Hazard
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. · FDA Class II
Units
18 worldwide and 10, in the U.S.
Sold at
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Description
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Product
Proteus 235 and Proteus ONE proton therapy systems
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →