FDA-Device2023-08-16Class II
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Philips North America
Hazard
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Sold states
US Nationwide. Global Distribution.
Affected count
601 Total
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2398-2023Don't want to check this manually?
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