Device recall
Z-1880-2018: Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The…
FDA device recall · Class II · Visaris DOO
Key facts
| Recall number (Z-number) | Z-1880-2018 |
|---|---|
| Recall event | 79848 |
| Product | Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited… |
| Product code | KPR |
| Recalling firm | Visaris DOO |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2019 |
| 510(k) numbers | K160620 |
| FEI number | 3012569470 |
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