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Health Canada Medical devices

Intelepacs

Issued December 31, 2021
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
Hazard description
Inaccurate test or measurement results
Product
Product name
Intelepacs
Reference
ID
RA-63778