FDAClass IIFebruary 8, 2017

MEVION S250-Proton Radiation Therapy Product Usage recall

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

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

An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

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?

S250-0002 and S250-0003

Product
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Recalling firm
Mevion Medical Systems, Inc.
Quantity
2 units
Distribution
US Nationwide in the states of OK, NJ
Recall date
February 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls