Device recall
Z-1132-2007: GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software…
FDA device recall · Class II · General Electric Medical Systems Information Technology
Key facts
| Recall number (Z-number) | Z-1132-2007 |
|---|---|
| Recall event | 37640 |
| Product | GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA. |
| 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