IBA Proton Therapy System - PROTEUS 235. PTS-11 recall
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning…
Why was IBA Proton Therapy System - PROTEUS 235. PTS-11 recalled?
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
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?
UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
- Product
- IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning…
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 5 (US), 9 (OUS)
- Distribution
- Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
- Recall date
- November 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)