Health product recall

Intelepacs

Last updated

Summary

Product
Intelepacs
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Intelepacs Version 4-10-1 and above INTELEPACS

Issue

There is a possibility that a patient's final report sent out of Intelepacs contains the preliminary text instead of the final report text. This issue can manifest itself only:
- In specific pacs-driven workflow configurations (e.g. multi-method reporting with transcriptionist worklist) where the signing step is handled by Intelepacs,
- Specifically when a network connectivity problem occurs between the server the user is connected to and the primary RIS gateway server (rig) of the system, and
- When the rig servers are not fully synchronized.

Recall start date: Apr 25, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Intelerad Medical Systems Incorporated

800 Boulevard De Maisonneuve Est, Montreal, Quebec

Canada, H2L 4L8

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64138

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe