Agency classClass IIOur severity:High FDA (Devices)·Z-0055-2025·Announced 2024-10-16

Enterprise Imaging XERO Viewer medical software reference line placement error

Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification without reported hospitalizations, injuries, or illnesses. The hazard is theoretical—incorrect image display poses potential risk of misdiagnosis, but no actual harm has been documented. This meets the criterion for High severity: risk-of-harm medical device defect without confirmed injury.

Plain-English summary

Enterprise Imaging XERO Viewer, a software application used for medical imaging viewing, is being recalled due to a display defect affecting versions 8.0.0 through 8.4.1. The defect causes reference lines and crosshairs to be incorrectly positioned on scout and localizer images when those images have non-square pixel spacing.

When reference lines are incorrectly placed, the display of anatomical locations may shift unintentionally, potentially leading to misdiagnosis or mistreatment. The software is used by healthcare facilities and healthcare professionals for reference and diagnostic viewing of multispecialty medical imaging data across the United States and numerous countries worldwide.

Agfa Healthcare NV, the manufacturer, has classified this as a Class II recall. Users of Enterprise Imaging XERO Viewer should contact Agfa Healthcare or check their website for software updates that address this display defect. Healthcare facilities should verify that their installations have been updated to corrected software versions.

The recalled product

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…
Manufacturer: Agfa Healthcare NV
Category: Medical Device — Diagnostic Imaging Software
Hazard: display-error
misdiagnosis-risk
reference-line-misplacement
Affected units: 801

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Agfa Healthcare NV

See all →

High
Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect
FDA (Devices) · 2023-02-01
Moderate
Agfa Healthcare Recalls Enterprise Imaging Desktops Due to Sorting Error
FDA (Devices) · 2018-10-17

Same hazard · display error