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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
Recalled March 23, 2016 · FDA recall Z-1098-2016 · Deerfield Imaging
Hazard
Emergency helium venting lines (i.e. quench lines) may not have been properly installed. · FDA Class II
Units
35 USA, 14 OUS
Sold at
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.
Description
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Product
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).
Manufacturer(s)
Deerfield Imaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →