FDA-Device2023-08-16Class II
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
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 S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2023Don't want to check this manually?
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