Device recall
Z-1045-2017: Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number…
FDA device recall · Class II · DICOM GRID INC
Key facts
| Recall number (Z-number) | Z-1045-2017 |
|---|---|
| Recall event | 76187 |
| Product | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. |
| Product code | LLZ |
| Recalling firm | DICOM GRID INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2017 |
| 510(k) numbers | K152977 |
| 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