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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS IMRI 1.5T AND 3T S System

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 Class 2 Device Recall IMRIS IMRI 1.5T AND 3T S Systemsee related information
Date Initiated by FirmApril 04, 2018
Create DateMay 04, 2018
Recall Status1 Terminated 3 on July 22, 2020
Recall NumberZ-1645-2018
Recall Event ID 79816
510(K)NumberK133692 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
Code Information Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
FEI Number 3010326005
Recalling Firm/
Manufacturer		 Deerfield Imaging, Inc.
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact
763-203-6300
Manufacturer Reason
for Recall		The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
FDA Determined
Cause 2		Device Design
ActionIMRIS sent Service bulletin T200627-B01 Rev dated March 14, 2018. - through email to all affected customers. The letter identified the affected product, the problem, and the actions required to be taken by the customer. For questions contact IMRIS Customer Support 866-475-0525.
Quantity in Commerce10 units
DistributionWorldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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