medical Class II Updated 2024-10-02

Philips North America Llc recalls SmartPath to Ingenia Elition X - For use as a diagnostic dev

Recalled Product

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118


Hazard / Issue

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)00884838099746(21) Serial Numbers: 85661 85676
View official government recall

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