FDAClass IINovember 23, 2016

MEVION S250 Product Usage: Proton Radiation Therapy recall

MEVION S250 Product Usage: Proton Radiation Therapy

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

Completing Setup Without Program Move Complete Can Cause An Isocenter Error

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: S250-0001 through S250-0006

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