Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical
FDA device recall Z-0055-2025 · posted 2024-10-10 · Open, Classified
Recall details
- Recalling firm
- Agfa Healthcare NV
- Reason for recall
- 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.
- Action taken
- AGFA issued Urgent: Mandatory Correction Important Information on 9/10/24. Letter states reason for recall, health risk and action to take: AGFA HealthCare will provide the software corrections for the affected versions. A patch is available for each of the following XERO Viewer version streams: - 8.4.x - 8.3.x - 8.2.x - 8.1.4.x - 8.1.2.x For versions of XERO Viewer prior to 8.1.2, the issue can be prevented from happening at your site by: - Using the XERO Viewer Extended Tools component (Xtend), if enabled. - Using the Enterprise Imaging Desktops viewer. - There is an option to disable the features affected by this issue. This can be configured by your administrator or contact AGFA Support. Our Support organization representative will contact all customers on any of these versions and coordinate the correction activity. The patch installation will not require any downtime. We request that you complete and return the attached mandatory feedback form. Please direct questions or concerns to your AGFA HealthCare Customer Support, and please reference PRB0762354. AGFA HealthCare Customer Support: 1.866.599.3868
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 801 units
- Distribution
- US Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile, Canada, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Georgia, Gr
- Date initiated
- 2024-09-06
- Date posted
- 2024-10-10
- Location
- Mortsel, Belgium
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Enterprise Imaging XERO Viewer 8.1 (K170434) | Agfa Healthcare N.V. | 2017-07-03 |