medical Class II Updated 2018-04-25

Philips Electronics North America Corporation recalls Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magn

Recalled Product

Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.


Hazard / Issue

Potential risk for helium gas inside the MR examination room during a magnet quench

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: None
View official government recall

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