IBA Proton Therapy System - PROTEUS 235 - Designed to recall
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
Why was IBA Proton Therapy System - PROTEUS 235 - Designed to recalled?
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
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: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator
- Product
- IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 2 units
- Distribution
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- Recall date
- June 12, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)