Events

Recall of IntelePACS Picture Archiving Communications System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intelerad Medical Systems 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
    52761
  • Event Risk Class
    Class 2
  • Event Number
    Z-1885-2009
  • Event Initiated Date
    2008-10-27
  • Event Date Posted
    2009-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83918
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    Product software versions 3.5.2.P1 to 3.5.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.
  • Action
    Intelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to quality@intelerad.com. For further information, contact Intelerad Medical Systems at 1-514-931-6222.

Device

IntelePACS Picture Archiving Communications System
  • Model / Serial
    InteleViewer software versions 3.5.2.P1 to 3.3.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
  • Product Description
    IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.
  • Manufacturer
    Intelerad Medical Systems Inc.

Manufacturer

Intelerad Medical Systems Inc.