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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS intraoperative MRI Systems: Neuro IISE, Neuro IIISV, iMRI 1.5T A, iMRI 3TS

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  Class 2 Device Recall IMRIS intraoperative MRI Systems: Neuro IISE, Neuro IIISV, iMRI 1.5T A, iMRI 3TS see related information
Date Initiated by Firm February 10, 2016
Date Posted March 11, 2016
Recall Status1 Terminated 3 on April 05, 2017
Recall Number Z-1098-2016
Recall Event ID 73421
510(K)Number K061916  K071099  K083137  K133692  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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).
Code Information 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.
Recalling Firm/
Manufacturer		 Deerfield Imaging
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact
866-475-0525
Manufacturer Reason
for Recall		 Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = IMRIS, INC.
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