Agfa Healthcare NV Recall: Enterprise Imaging XERO Viewer- software application used for r
Agfa Healthcare NV Recall: Enterprise Imaging XERO Viewer- software application used for r is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Agfa Healthcare NV; Product: Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medic
| Recalling firm | Agfa Healthcare NV |
|---|---|
| Product | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s) |
| Reason for recall | Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile, Canada, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Georgia, Greece, Hong Kong, Iceland, Ireland, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Luxembourg, Me |
| Recall initiated | 20240906 |
| Recall number | Z-0055-2025 |
| Category | device |
| Country | Belgium |
$29/mo
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