FDAClass IIJuly 12, 2017

Proteus 235 recall: Software Issue

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton…

Why was Proteus 235 recalled?

Software issue

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 Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

Product
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton…
Recalling firm
Ion Beam Applications S.A.
Quantity
6 worldwide and 5 in the U.S.
Distribution
Distributed to FL, VA, IL, NJ, WA and South Korea
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls