Philips Electronics North America Corporation recalls Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can…

Recall date

March 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1436-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic o…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Conversion SmarthPath to dStream for 1.5T, Model 781260 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.