FDAClass IFebruary 25, 2015

Echostar Spica 1.5T MRI system recall

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

Why was Echostar Spica 1.5T MRI system recalled?

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

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: D-ESP-1001 and D-ESP-1003

Product
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Recalling firm
Alltech Medical Systems America Inc
Quantity
2 units
Distribution
US Distribution in the state of Maryland.
Recall date
February 25, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls