Device recall
Z-0929-2020: Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software…
FDA device recall · Class II · Dexcom Inc
Key facts
| Recall number (Z-number) | Z-0929-2020 |
|---|---|
| Recall event | 84290 |
| Product | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes… |
| Product code | MDS |
| Recalling firm | Dexcom Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2022 |
| PMA numbers | P120005, P120005S033 |
| FEI number | 3004753838 |
At a glance
- None 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