FDAAugust 11, 2021device

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

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

The hazard

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

What to do

FDA enforcement status: Completed

Brands named

philips north americaphilipsphilips north

UPCs

00884838068421

Recall history

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

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Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347 — Recall Details · AllClear