Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0055-2025 — 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.

U.S. FDA — Device Enforcement · Belgium · 2024-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0055-2025
Date of alert
2024-09-06
Country / jurisdiction
Belgium
Risk level
Class II
Risk type
recall
Brand
Agfa Healthcare NV
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05400874000710
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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