Device recall
Z-1104-2020: Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version…
FDA device recall · Class II · Dexcom Inc
Key facts
| Recall number (Z-number) | Z-1104-2020 |
|---|---|
| Recall event | 84436 |
| Product | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804 |
| Product code | QBJ |
| Recalling firm | Dexcom Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2023 |
| 510(k) numbers | K191450 |
| FEI number | 3004753838 |
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