Device recall
Z-2035-2019: Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the…
FDA device recall · Class II · Spacelabs Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-2035-2019 |
|---|---|
| Recall event | 83220 |
| Product | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. |
| Product code | DQK |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2022 |
| 510(k) numbers | K110779 |
| FEI number | 3010157426 |
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