Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Intra operative MRI Systems: Neuro II-SE Recalled by Deerfield Imaging Due to Emergency helium venting lines (i.e. quench lines) may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Deerfield Imaging directly.
Affected Products
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).
Quantity: 35 USA, 14 OUS
Why Was This Recalled?
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Where Was This Sold?
This product was distributed to 19 states: CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, WI
About Deerfield Imaging
Deerfield Imaging has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report