Enterprise Imaging Desktops Enterprise Imaging Desktops — Class II medical device recall Z-0101-2019
Terminated recall by Agfa Healthcare NV, reported 2018-10-17, distributed in CA, FL, IN, LA, MN, PA, PR, SC…. Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop,
| Recall number | Z-0101-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa Healthcare NV, Mortsel, Belgium |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-11 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2020-04-03 |
| Distributed | CA, FL, IN, LA, MN, PA, PR, SC, TX, VA |
| Countries outside the US | CA |
| Quantity | 17 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0101-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.