Agfa Healthcare NV 2024-10-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0055-2025
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic… Recall
Issued October 16, 2024 · Agfa Healthcare NV
In October 2024, Agfa Healthcare NV recalled the Enterprise Imaging XERO Viewer- software application used for reference and diagnostic…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Enterprise Imaging XERO Viewer- software application used for reference and diagnostic… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Agfa Healthcare NV to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Agfa Healthcare NV
- Category
- Health
- Recall date
- October 16, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile, Canada, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denma
- Recall number
- FDA-Z-0055-2025
- Made in
- Belgium
- Issuing agency
- FDA
In context
- Agfa Healthcare NV has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.