Device recall
Z-0416-2026: Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810…
FDA device recall · Class II · Spacelabs Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-0416-2026 |
|---|---|
| Recall event | 97686 |
| Product | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers… |
| Product code | DQK |
| Recalling firm | Spacelabs Healthcare, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152881 |
| FEI number | 3002807992 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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