Official recall record
Enterprise Imaging XERO Viewer
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-09-18
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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