IBA Proton Therapy System - PROTEUS 235 recall
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Why was IBA Proton Therapy System - PROTEUS 235 recalled?
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.
- Product
- IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)