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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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