Device recall
Z-3013-2026: Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software…
FDA device recall · Class II · Midmark Corporation
Key facts
| Recall number (Z-number) | Z-3013-2026 |
|---|---|
| Recall event | 99404 |
| Product | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. |
| Product code | DRG |
| Recalling firm | Midmark Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220526 |
| FEI number | 1523530 |
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