FDA-Device2022-12-14Class II

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

Philips North America Llc
Hazard

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

Sold states
US Nationwide.
Affected count
566 total
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0459-2023

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