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Health Canada Medical devices

Enterprise Imaging XERO Viewer

Issued September 18, 2024
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
Hazard description
Performance
Product
Product name
Enterprise Imaging XERO Viewer
Reference
ID
RA-76050