Events

Recall of IMRIS IMRI 1.5T AND 3T S System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deerfield Imaging, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79816
  • Event Risk Class
    Class 2
  • Event Number
    Z-1645-2018
  • Event Initiated Date
    2018-04-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163559
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    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.
  • Action
    IMRIS 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.

Device

IMRIS IMRI 1.5T AND 3T S System
  • Model / Serial
    Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
  • Product Description
    IMRIS 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.
  • Manufacturer
    Deerfield Imaging, Inc.

Manufacturer

Deerfield Imaging, Inc.
  • Manufacturer Address
    Deerfield Imaging, Inc., 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Manufacturer Parent Company (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA