FDAClass IIJanuary 16, 2019

Mevion S250i recall

MEVION S250i

Why was Mevion S250i recalled?

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

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?

DI: (01)00864366000124 Serial Number: S250i-0007

Product
MEVION S250i
Recalling firm
Mevion Medical Systems, Inc.
Quantity
1 unit
Distribution
DC
Recall date
January 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls