medical Class II Updated 2018-04-25

Philips Electronics North America Corporation recalls Intera 0.5T Standard, Model 781101 Product Usage: Indica

Recalled Product

Intera 0.5T Standard, Model 781101 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: (Added 6/25/18): 6051 6003 6046 6004
View official government recall

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