Enterprise Imaging XERO Viewer
Brand(s)
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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