Intra operative MRI Systems: Neuro II-SE , Neuro III-SV… recallZ-1098-2016 · Deerfield Imaging · initiated Feb 10, 2016
Class II Terminated All recalls posted in March 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Deerfield Imaging or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
FDA root cause category: Device Design
What the company is doing
Consignees were sent a IMRIS "Urgent Field Safety Notice" letter dated February 10, 2016. The letter described the problem and the product involved in the recall. The firm also stated that it is important that customers review the portion of the quench line vent described and ensure that it is installed to the specifications supplied as part of the Planning Guide. Customers were reminded that it is important to have an emergency plan in place in the event Helium gas escapes into the magnet room or any other area. For questions customers can contact their local customer support hotline or +1-866-475-0525.
Recall details
- Recall number
- Z-1098-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 10, 2016
- Posted by the FDA
- Mar 11, 2016
- Recalling firm
- Deerfield Imaging
- Quantity
- 35 USA, 14 OUS
- Product code
- LNH
- FDA submissions
- K061916, K071099, K083137, K133692
- Distribution
- 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.
Product description
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).
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
7 devices cleared under K061916, K071099, K083137, K133692 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- iMRI 3T S OR-DR, 116118-000IMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall5 reports
- iMRI 3T S OR-DR-OR 116053-000IMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall2 reports
- iMRI 3T S OR-DR-OR 116117-000IMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- iMRI 3T S OR-DR 116119-000IMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Neuro III-SV iMRI SystemIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Neuro III-SV iMRI SystemIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Neuro II-SE 105000-00XIMRIS Imaging, Inc. · System, Nuclear Magnetic Resonance Imaging1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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