CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Intra operative MRI Systems: Neuro Ii-se , Neuro Iii-sv recalled

Deerfield Imaging is recalling Intra operative MRI Systems: Neuro Ii-se , Neuro Iii-sv, iMRI 1.5T A, and iMRI 3T S, distributed in 19 states. The recall was initiated on 10 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.

Quantity recalled35 USA, 14 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1098-2016
FDA event ID: 73421
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2016
FDA classified: 11 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

10 Feb 2016	Recall initiated by company
11 Mar 2016	Classified by FDA	+30 days
23 Mar 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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).

Where it was 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.

California Connecticut Florida Georgia Illinois Indiana Massachusetts Maryland Minnesota Missouri North Carolina New Hampshire Ohio Oregon Pennsylvania Texas Utah Virginia Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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