FDAClass IINovember 23, 2016

MEVION S250 Product Usage: Proton Radiation Therapy recall

MEVION S250 Product Usage: Proton Radiation Therapy System

Why was MEVION S250 Product Usage: Proton Radiation Therapy recalled?

Recovery of Incorrect Isocenter -operational change

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: S250-0001 through S250-0006

Product
MEVION S250 Product Usage: Proton Radiation Therapy System
Recalling firm
Mevion Medical Systems, Inc.
Quantity
6 units
Distribution
US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls