FDAClass IIApril 26, 2017

Proteus 235 recall

Proteus 235, Proton Therapy System

Why was Proteus 235 recalled?

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

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: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Product
Proteus 235, Proton Therapy System
Recalling firm
Ion Beam Applications S.A.
Quantity
2 worldwide, 1 in U.S.
Distribution
Distribution in US (to Louisiana), and France.
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls