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
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Sold states
US Nationwide. Global Distribution.
Affected count
640 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-2395-2023Don't want to check this manually?
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