Device recall
Z-2479-2020: BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors…
FDA device recall · Class II · Preventice Services, LLC
Key facts
| Recall number (Z-number) | Z-2479-2020 |
|---|---|
| Recall event | 85233 |
| Product | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors. |
| Product code | DSI |
| Recalling firm | Preventice Services, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2022 |
| 510(k) numbers | K151188 |
| FEI number | 3005332083 |
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