FDASeptember 3, 2024device

Ingenia 1.5T -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: 1) 782115 2) 782101 3) 782140

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

008848380990430088483809827500884838108646

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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