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Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti
Recalled August 16, 2023 · FDA recall Z-2395-2023 · 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. · FDA Class II
Units
640 total
Sold at
US Nationwide. Global Distribution.
Description
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Product
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →