Device recall
Z-1561-2020: Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous…
FDA device recall · Class II · Dexcom Inc
Key facts
| Recall number (Z-number) | Z-1561-2020 |
|---|---|
| Recall event | 84891 |
| Product | Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. |
| Product code | PQF |
| Recalling firm | Dexcom Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2022 |
| PMA numbers | P120005 |
| FEI number | 3004753838 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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