Device 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.
Z-2173-2018
Product summary
- Event
- Event 80222
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-2173-2018
Official wording
Reason: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Code information: Code/Serial Numbers: PAT.000, 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, SAT.126.
Distribution pattern: Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
Derived failure modes
-
Unknown
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.