FDAClass IIDecember 14, 2022

Philips SmartPath to Ingenia Elition X MR System recall

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

Why was Philips SmartPath to Ingenia Elition X MR System recalled?

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.

Product
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Recalling firm
Philips North America Llc
Quantity
566 total
Distribution
US Nationwide.
Recall date
December 14, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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