Device recall
Z-1134-2007: GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software…
FDA device recall · Class II · General Electric Medical Systems Information Technology
Key facts
| Recall number (Z-number) | Z-1134-2007 |
|---|---|
| Recall event | 37640 |
| Product | GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue… |
| Product code | DQK |
| Recalling firm | General Electric Medical Systems Information Technology |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2011 |
| 510(k) numbers | K050093 |
| FEI number | 2124823 |
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