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Intelepacs
Official notice
31 Dec 2021
Last checked
31 Dec 2021
An official Health Canada notice concerns Intelepacs. 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 Published 2021-12-31.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63778
Official notice
2021-12-31
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Intelerad Medical, Intelepacs.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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