Device recall
Z-2270-2010: Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure…
FDA device recall · Class II · Spacelabs Healthcare, Incorporated
Key facts
| Recall number (Z-number) | Z-2270-2010 |
|---|---|
| Recall event | 50226 |
| Product | Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical… |
| Product code | DQK |
| Recalling firm | Spacelabs Healthcare, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2010 |
| 510(k) numbers | K063490 |
| 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