Agfa Healthcare recalls Enterprise Imaging Desktops (Radiology/Cardiology) versions 8.0-8.1 SPs due to study order disruption when adding comparison studies. Affected units may show non-chronological study thumbnails.
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.
Agfa Healthcare is recalling Enterprise Imaging Desktops (Radiology and Cardiology suites) because adding a comparison study can disrupt the chronological order of study thumbnails. This means the most recent study may not appear at the top of the list, potentially causing confusion in medical image review workflows.
When a comparison study is added to the Clinical Side Bar, the system may reorder studies incorrectly. This causes thumbnail images to no longer show the most recent study at the top, which could lead to workflow confusion but does not pose a safety risk.
Medical professionals using Agfa Enterprise Imaging Desktops for radiology or cardiology imaging systems. Those with specific versions 8.0.0 through 8.1 SP2 are most affected.
Check if your Enterprise Imaging Desktop is a Radiology or Cardiology suite version 8.0.0 through 8.1 SP2. The system was deployed as a departmental Picture Archiving and Communications System (PACS).
Verify if adding a comparison study changes the chronological order of study thumbnails in the Clinical Side Bar.
No, the recall does not require stopping use. The issue is a workflow disruption, not a safety hazard.
Versions 8.0.0 through 8.1 SP2 (including all service packs).
Check if your Enterprise Imaging Desktop is a Radiology or Cardiology suite version 8.0.0 through 8.1 SP2 deployed as a departmental PACS.
We’ve drafted a message you can send Agfa Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2019 — Agfa Healthcare Agfa Healthcare Hello, I own a Agfa Healthcare that is covered by recall Z-0101-2019 from Agfa Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
