Events

Recall of MONTERIS MEDICAL NEUROBLATE SYSTEM

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

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
    78315
  • Event Risk Class
    Class 1
  • Event Number
    Z-0194-2018
  • Event Initiated Date
    2017-10-05
  • 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=159161
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    The firm received complaints that involved an unanticipated interaction between a neuroblate system and 1.5 tesla (1.St) mri systems.
  • Action
    The firm issued advisory notice 10/05/2017. The notice discussed complaints received that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.5T) MRI systems. The notice provided added recommendations for all NeuroBlate users to mitigate the anomaly.

Device

MONTERIS MEDICAL NEUROBLATE SYSTEM
  • Model / Serial
    All serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
  • Manufacturer
    Monteris Medical Corp

Manufacturer

Monteris Medical Corp
  • Manufacturer Address
    Monteris Medical Corp, 14755 27th Ave N Ste C, Plymouth MN 55447-4866
  • Source
    USFDA