FDAClass IIDecember 14, 2022

Philips Ingenia Elition S MR System recall

Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137

Why was Philips Ingenia Elition S 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 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.

Product
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
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)
Open FDA enforcement record Latest recalls