FDAClass IIJanuary 27, 2016

Accusorb MRI MAC7010 Product Usage: Radio frequency recall

Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Why was Accusorb MRI MAC7010 Product Usage: Radio frequency recalled?

When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

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?

All

Product
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Recalling firm
MWT Materials, Inc.
Quantity
1 units
Distribution
US Nationwide Distribution in the states of NY and MA.
Recall date
January 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls