Device recall
Z-2211-2008: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-2211-2008 |
|---|---|
| Recall event | 48683 |
| Product | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW . Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K041476 |
| FEI number | 2126677 |
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