Device recall
Z-1818-2022: Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and…
FDA device recall · Class II · DICOM Grid, Inc. d/b/a Ambra Health
Key facts
| Recall number (Z-number) | Z-1818-2022 |
|---|---|
| Recall event | 90817 |
| Product | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. |
| Product code | LLZ |
| Recalling firm | DICOM Grid, Inc. d/b/a Ambra Health |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202335 |
| FEI number | 3008776294 |
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