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FDAFebruary 10, 2016device

Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

What to do

FDA enforcement status: Terminated

Brands named

deerfield imagingdeerfield

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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