FDA Device recall Z-0101-2019
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archivin…
- FDA Device
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archivin… by Agfa Healthcare Nv, citing 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 Clinic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0101-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-03 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Agfa Healthcare Nv |
| Distribution | CA, FL, IN, LA, MN, PA, PR, SC, TX, VA |
Product
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.
Reason
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2019%22
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