FDAClass IIJanuary 16, 2019

Proteus 235 Product Usage: The Proton Therapy System recall

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

Why was Proteus 235 Product Usage: The Proton Therapy System recalled?

There is a risk of detachment of the Compact Gantry Rolling Floor.

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?

SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109

Product
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce…
Recalling firm
Ion Beam Applications S.A.
Quantity
7
Distribution
Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Recall date
January 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls