Agfa Healthcare NV: 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)

Recall number

Z-0055-2025

Recalling firm

Agfa Healthcare NV

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)

Status

Open, Classified

Initiated

2024-09-06

Posted

2024-10-10

Terminated

not on file

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.

Root cause

Software design

Action

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

Quantity

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, 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

Lot, serial or model codes

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

510(k) numbers

["K170434"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3009471886

Firm city

Mortsel

Firm state

not on file

Firm country

Belgium

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy