Reported Oct 17, 2018 · Terminated

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a…

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

Is this the product you have?

  • Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Lot codes and dates
    • Versions 8.0.0
    • 8.0.0 SP1 & 8.0.0 SP2
    • 8.0.1
    • 8.0.1 SP1
    • 8.0.1 SP2
    • 8.0.1 SP3
    • 8.0.1 SP4
    • 8.0.1 SP5
    • 8.0.1 SP6
    • 8.1
    • 8.1 SP1
    • 8.1 SP2
Amount recalled
17

Where it was sold

Why it was recalled

Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.

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

Notice updated Apr 3, 2020 · Data as of Sep 19, 5:29 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.