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FDA-Device2024-10-16Class II

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)

Agfa Healthcare NV
Hazard

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.

Sold states
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, Mexico, Netherlands, Nicaragua, Norway, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Tanzania, Tunisia, United Arab Emirates, United Kingdom
Affected count
801 units
Manufactured in
Septestraat 27, Mortsel, Belgium
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0055-2025

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