Events

Recall of NEURO II-SE INTRA-OPERATIVE MRI SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    20126
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Manufacture has reported discovering quench lines installed by the system owner which do not meet the specifications provided. if the quench line is not installed properly or is restricted or obstructed when a quench occurs it could cause helium gas to vent directly into the mri room or other areas.

Device

NEURO II-SE INTRA-OPERATIVE MRI SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: NEURO II-SE (Lot serial: 40263); Model Catalog: NEURO II-SE (Lot serial: M00106); Model Catalog: NEURO II-SE (Lot serial: 40619); Model Catalog: NEURO II-SE (Lot serial: 40475)
  • Product Description
    Neuro II SE Intra-Operative MRI System
  • Manufacturer
    DEERFIELD IMAGING INC.

Manufacturer

DEERFIELD IMAGING INC.