Deerfield Imaging recalls Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic re…

Recall date

February 10, 2016

Source

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

Recall number

Z-1098-2016

FDA classification

Class II

Brand / firm

Deerfield Imaging

Sold / distributed

Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.

Why it was recalled

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

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

What was recalled

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).