Health product recall

Intelepacs

Last updated

Summary

Product
Intelepacs
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Intelepacs EnhancedView 1.17.4 to 1.19.19 InteleViewer 4-3-1 R1 to 5-4-1 INTELEPACS

Issue

When the specific circumstances described below occur, there is a possibility of displaying distorted images along with erroneous measurements. the distortion and measurement difference could affect decisions regarding patient care.
1- When using advanced visualisation to reconstruct MR, CT and pet images that contain non-square pixels, the reconstructed image is incorrect. non-square pixels occur when the row and column pixel spacing values are different. measurements made on this image are also consequently erroneous. this issue does not affect measurements made on regular 2D views.
2- When using advanced visualisation in the enhanced viewer to reconstruct MR and CT images that have nonorthogonal volume axes (e.g. gantry tilt), linear measurements will be incorrect due to the use of an incorrect formula. this only occurs for measurements made on a re-oriented view (e.g. MPR). Inteleviewer can be affected when using the EV advanced visualisation view embedded inside inteleviewer (inteleviewer versions 5.4.1.R1 and later).

Recall start date: 2021-12-15

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-63778

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