Health product recall

IntelePACS (2020-01-21)

Starting date:
January 21, 2020
Posting date:
February 7, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72265

Last updated: 2020-02-07

Affected Products

IntelePACS

Reason

The recall is a pro-active field action to prevent occurrence of the problem at other client sites.

When the user has opened multiple orders in InteleViewer to dictate for different patients, and switches rapidly (subsecond) between them many times, it is possible for the viewer to display images from one patient while showing the patient record tab and dictation system for another. If the user takes any action in the viewer (including window focus), the views (images and dictation) will resynchronize with the patient record tab.

This desynchronization situation can also arise when using a 3rd party dictation system, if the radiologist switches to the image viewing windows of a different patient using the operating system and does not interact at all with the viewer, while InteleViewer  is waiting for the dictation system to complete a previous switch from one patient to another. Again, if the user takes any action in the viewer (including window focus), all of the views will resynchronize.

Affected products

IntelePACS

Lot or serial number

Versions 4-17-1 and higher.

Model or catalog number

IntelePACS

Companies
Manufacturer

Intelerad Medical Systems Incorporated

895 De La Gauchetiere Street West, 4th floor

Montreal

H3B 4G1

Quebec

CANADA