Events

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

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

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
    73421
  • Event Risk Class
    Class 2
  • Event Number
    Z-1098-2016
  • Event Initiated Date
    2016-02-10
  • Event Date Posted
    2016-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144171
  • 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
    Emergency helium venting lines (i.E. quench lines) may not have been properly installed.
  • 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.

Device

Device Recall IMRIS intraoperative MRI Systems: Neuro IISE, Neuro IIISV, iMRI 1.5T A, iMRI 3TS
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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).
  • Manufacturer
    Deerfield Imaging

Manufacturer

Deerfield Imaging