Device recall
Z-0810-2020: Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands…
FDA device recall · Class II · Suntech Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0810-2020 |
|---|---|
| Recall event | 84531 |
| Product | Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10). |
| Product code | DXN |
| Recalling firm | Suntech Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2023 |
| 510(k) numbers | K151520 |
| FEI number | 1036863 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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