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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91357

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

Open FDA event record

Event summary

Timeline bucket
December 05, 2022
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

Agfa HealthCare Enterprise Imaging XERO Viewer

Z-1004-2023
Recall number
Z-1004-2023
Initiated
December 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Agfa Healthcare NV
Quantity
110 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

There is a software defect that can cause issues with images.

Code information

Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710

Distribution pattern

Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa