FDAClass IIAugust 5, 2020

Proteus 235 The Proton Therapy System - Proteus 235 recall

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a…

Why was Proteus 235 The Proton Therapy System - Proteus 235 recalled?

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

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?

Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019

Product
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a…
Recalling firm
Ion Beam Applications S.A.
Quantity
2 Units
Distribution
US: VA OUS: Belgium
Recall date
August 5, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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