Z-1098-2016Class II

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

Name: Z-1098-2016 Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a...
Creator: Deerfield Imaging
Published: 2016-02-10
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2016-02-10 / Terminated / root cause: design

FDA source

Deerfield Imaging began a recall of 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) on 2016-02-10. FDA classified it as Class II and gives the reason as "Emergency helium venting lines (i.e. quench lines) may not have been properly installed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1098-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-10
Posted: 2016-03-11
Terminated: 2017-04-05
Recalling firm: IMRIS Imaging, Inc.
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).
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 35 USA, 14 OUS
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1098-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-11

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)