# FDA recall Z-0055-2025

> **Agfa Healthcare NV** · Class II · device recall initiated 2024-09-06.

## 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 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.

## 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

## Key facts

- **Recall number:** Z-0055-2025
- **Recalling firm:** Agfa Healthcare NV
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-06
- **Report date:** 2024-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mortsel, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0055-2025

## Citation

> AI Analytics. FDA recall Z-0055-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0055-2025. Source: US FDA. Licensed CC0.

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