Philips North America Llc recalls Ingenia Elition S-Magnetic Resonance Medical Electrical Syst
Recalled Product
Ingenia Elition S-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 Number: 781357 (OUS)
Hazard / Issue
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Issued by
FDA
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