medical Class II Updated 2018-04-25

Philips Electronics North America Corporation recalls Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103

Recalled Product

Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 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): 7149 7210 7082 7212 7015 7174 7081 10327 7073 10332 7063 7040 7119 7095 7272 10104 7005 7213 7057 10326 7128 10339 7230 10329 7183 7098 10053 7080 7011 7178 7139 7126 10192 7217 7066 7171 7136 7038 7050
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