FDAClass IIApril 5, 2017

Proteus 235 recall

Proteus 235

Why was Proteus 235 recalled?

The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

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.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120

Product
Proteus 235
Recalling firm
Ion Beam Applications S.A.
Quantity
8 worldwide, 4 in U.S.
Distribution
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls