Mortsel, Belgium
Agfa Healthcare NV recalls
3 recalls recorded since 2018, most recently on 6 September 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 September 2024
- 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.
- Distribution
- 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, Me
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 5 December 2022
- Reason
- There is a software defect that can cause issues with images.
- Distribution
- Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1004-2023
- Agfa HealthCare Enterprise Imaging XERO Viewer
Terminated Class II Medical devices
- Recall started
- 3 August 2018
- Terminated
- 3 April 2020
- Reason
- 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.
- Distribution
- US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0101-2019
- Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.