Recall archive / FDA device enforcement
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medi... — FDA record Z-0055-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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)
- 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.
- Classification
- Class II
- Recalling firm
- Agfa Healthcare NV
- Quantity
- 801 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0055-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 05400874000710 Software Versions affected: All versions of Enterprise Imaging XERO Viewer are affected 8.1.2 or higher 8.1.4 or higher 8.2.0.100 or higher 8.2.2.000 or higher 8.3.2.000 or higher 8.4.0.000 or higher Enterprise Imaging XERO Viewer main version streams 8.4.0, 8.4.1, 8.3.2, 8.3.1, 8.3.0, 8.2.2, 8.2.1, 8.2.0, 8.1.5, 8.1.4, 8.1.3, 8.1.2, 8.1.1, 8.1, 8.0.1, 8.0.0, ICIS View 2014.1, ICIS View 2014.2 |
Match all identifying details in the current notice. A brand name alone is not enough.
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, 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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 16, 2024
- Recall initiation date
- Sep 6, 2024
- Center classification date
- Oct 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.