FDAClass IIMay 13, 2015

GE Discovery MR950 MRI system recall

GE Discovery MR950 MRI system

Why was GE Discovery MR950 MRI system recalled?

The alignment lasers are missing the labels required by radiation safety regulations.

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?

Model Number - Discovery MR950

Product
GE Discovery MR950 MRI system
Recalling firm
GE Healthcare
Quantity
5 units (2 in US)
Distribution
US Distribution to the state of CA., and Internationally to Italy and Japan.
Recall date
May 13, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls