Health product recall

Enterprise Imaging XERO Viewer

Last updated

Summary

Product
Enterprise Imaging XERO Viewer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Enterprise Imaging XERO Viewer

All Versions

8.X

Issue

Agfa Healthcare has become aware of an issue related to orientation of 3D volumes using reference lines, active target localization, and series linking across multiple planes. A coding error has been identified in the initialization of pixel spacing in the XERO Viewer. This issue only applies to XERO Viewer. It does not apply to the XERO Viewer extended tools (Xtend) component or the enterprise imaging diagnostic desktop viewer.

Recall Start Date: September 10, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Agfa Healthcare N.V.

Septestraat 27, Mortsel, Belgium, 2640

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76050

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