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