Drug recall
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a…
FDA recall event 80998 · Class II · Agfa Healthcare NV
Key facts
| Event ID | 80998 |
|---|---|
| Recall numbers | Z-0101-2019 |
| Recalling firm | Agfa Healthcare NV |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 3, 2018 |
| Report date | Oct 17, 2018 |
| Termination date | Apr 3, 2020 |
| City | Mortsel |
| Country | Belgium |
| FEI number | 3009471886 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: