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U.S. Department of Health and Human Services

Class 2 Device Recall iMRX MRI and Angiography System

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  Class 2 Device Recall iMRX MRI and Angiography System see related information
Date Initiated by Firm November 26, 2019
Create Date December 31, 2019
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-0762-2020
Recall Event ID 84400
510(K)Number K101813  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography.
The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room.

The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.
Code Information Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.  
Recalling Firm/
Manufacturer		 Deerfield Imaging, Inc.
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact Service
866-475-0525
Manufacturer Reason
for Recall		 There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible
FDA Determined
Cause 2		 Component design/selection
Action An Urgent Field Safety Notice letter was sent to customers on 11/26/2019 via FedEx.. The letter state the issue, potential risk, the actions to be taken, and stated that the device will be modified. Questions can be directed to the service line at 1-866-475-0525.
Quantity in Commerce 6
Distribution CT, MA, VA. International distribution: Australia, Canada, and Qatar.
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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