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

FDA Recall #Z-0459-2023 — Class II — November 22, 2022

Recall #Z-0459-2023 Date: November 22, 2022 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

566 total

Distribution

US Nationwide.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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