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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95411

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Agfa Healthcare NV

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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)

Z-0055-2025
Recall number
Z-0055-2025
Initiated
September 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Agfa Healthcare NV
Quantity
801 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

Field note

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