Device recall
Z-0101-2019: Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology…
FDA device recall · Class II · Agfa Healthcare NV
Key facts
| Recall number (Z-number) | Z-0101-2019 |
|---|---|
| Recall event | 80998 |
| 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… |
| Product code | LLZ |
| Recalling firm | Agfa Healthcare NV |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2020 |
| 510(k) numbers | K111945 |
| FEI number | 3009471886 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database