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Devices
Device Recall Proteus 235 and Proteus ONE proton therapy systems
Model / Serial
Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Product Description
Proteus 235 and Proteus ONE proton therapy systems
Manufacturer
Ion Beam Applications S.A.
1 Event
Recall of Device Recall Proteus 235 and Proteus ONE proton therapy systems
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Manufacturer
Ion Beam Applications S.A.
Manufacturer Address
Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
Manufacturer Parent Company (2017)
Ion Beam Applications SA
Source
USFDA
Language
English
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