medical Class II Updated 2024-10-02

Philips North America Llc recalls Ingenia 3.0T CX - For use as a diagnostic device to obtain c

Recalled Product

Ingenia 3.0T CX - 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: 782105


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)00884838098312(21) Serial Numbers: 78547 78557 78559 78560 78562 78564 78565 78566
View official government recall

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