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Agfa Healthcare NV Recalls
3 recalls on record · October 17, 2018 to October 16, 2024 · Medical Devices
Recalls by year
18
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 16, 2024Medical DevicesFDA
Agfa Healthcare NV recalls Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical
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.
February 1, 2023Medical DevicesFDA
Agfa Healthcare NV recalls Agfa HealthCare Enterprise Imaging XERO Viewer
Hazard: There is a software defect that can cause issues with images.
October 17, 2018Medical DevicesFDA
Agfa Healthcare NV recalls Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departm
Hazard: Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.