Reported Feb 1, 2023 · Ongoing

Agfa HealthCare Enterprise Imaging XERO Viewer

Agfa Healthcare NV

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Agfa Healthcare NV · Septestraat 27 · Mortsel, N/A · N/A

Is this the product you have?

  • Agfa HealthCare Enterprise Imaging XERO Viewer
Lot codes and dates
  • Affected software versions includeXERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000
  • or higher UDI/DI05400874000710
Amount recalled
110 units

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.