Device recall
Z-0694-2013: Spacelabs Smart Disclosure System, Model 92810, is an integrated component of…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-0694-2013 |
|---|---|
| Recall event | 63931 |
| Product | Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. 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… |
| Product code | DQK |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2013 |
| 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