CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
Enterprise Imaging Desktops Enterprise Imaging Desktops recalled
Agfa Healthcare is recalling Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology, distributed in 10 states. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0101-2019
- FDA event ID
- 80998
- Recalling firm
- Agfa Healthcare, Mortsel
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 3 Aug 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +69 days |
| 17 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
CaliforniaFloridaIndianaLouisianaMinnesotaPennsylvaniaPuerto RicoSouth CarolinaTexasVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
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