FDAClass IIMarch 14, 2018

Proteus 235 recall

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a…

Why was Proteus 235 recalled?

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

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?

PAT.003 (KR), PAT.006 (US)

Product
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a…
Recalling firm
Ion Beam Applications S.A.
Quantity
3
Distribution
US Distribution to the state of :FL
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls