FDA Device recall Z-0055-2025
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-im…
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-im… by Agfa Healthcare Nv, citing 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 cr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0055-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-06 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Agfa Healthcare Nv |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 05400874000710 Software Versions affected: All versions of Enterprise Imaging XERO Viewer are affected 8.1.2…UDI-DI: 05400874000710 Software Versions affected: All versions of Enterprise Imaging XERO Viewer are affected 8.1.2 or higher 8.1.4 or higher 8.2.0.100 or higher 8.2.2.000 or higher 8.3.2.000 or higher 8.4.0.000 or higher Enterprise Imaging XERO Viewer main version streams 8.4.0, 8.4.1, 8.3.2, 8.3.1, 8.3.0, 8.2.2, 8.2.1, 8.2.0, 8.1.5, 8.1.4, 8.1.3, 8.1.2, 8.1.1, 8.1, 8.0.1, 8.0.0, ICIS View 2014.1, ICIS View 2014.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0055-2025%22
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