Events

Recall of ILUMAVision

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by IMTEC IMAGING L.L.C..

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
    53132
  • Event Risk Class
    Class 2
  • Event Number
    Z-2239-2009
  • Event Initiated Date
    2009-08-03
  • Event Date Posted
    2009-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84746
  • 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
    Picture archiving and communications system - Product Code LLZ
  • Reason
    Under certain circumstances, software version 2.1.0 has potential for incorrect data imaging and patient identification.
  • Action
    Firm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.

Device

ILUMAVision
  • Model / Serial
    ILUMAVision Version 2.1.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US - Foreign: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Egypt, France, Germany, Hong Kong, Italy, Korea, Malaysia, Mexico, The Netherlands, Poland, Saudi Arabia, Spain, Turkey, and United Kingdom
  • Product Description
    ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system || Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.
  • Manufacturer
    IMTEC IMAGING L.L.C.

Manufacturer

IMTEC IMAGING L.L.C.
  • Manufacturer Address
    IMTEC IMAGING L.L.C., 2401 N Commerce St, Ardmore OK 73401-1280
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA