Device recall
Z-1934-2020: CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
FDA device recall · Class II · Cuattro LLC
Key facts
| Recall number (Z-number) | Z-1934-2020 |
|---|---|
| Recall event | 85446 |
| Product | CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 |
| Product code | KPR |
| Recalling firm | Cuattro LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K161937 |
| FEI number | 3008364043 |
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