Proteus 235 and Proteus ONE proton therapy systems recall: Software Issue
Proteus 235 and Proteus ONE proton therapy systems
Why was Proteus 235 and Proteus ONE proton therapy systems recalled?
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Proteus 235 and Proteus ONE proton therapy systems
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 18 worldwide and 10, in the U.S.
- Distribution
- Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
- Recall date
- July 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)