Events

Recall of Device Recall IntelePACS

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

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
    68719
  • Event Risk Class
    Class 2
  • Event Number
    Z-2267-2014
  • Event Initiated Date
    2014-07-03
  • Event Date Posted
    2014-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128558
  • 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
    In specific situation a partially truncated file may be written to the intelepacs server. this partially truncated file still can be viewed by inteleviewer and inteleviewer will report to the user that the file in question is complete. this situation only occurs if a file is partially truncated.
  • Action
    Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.

Device

Device Recall IntelePACS
  • Model / Serial
    software versions 3-8-1 to 4-9-1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
  • Product Description
    IntelePACS software versions 3-8-1 to 4-9-1, || Product Usage: || IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
  • Manufacturer
    Intelerad Medical Systems

Manufacturer

Intelerad Medical Systems