Device recall
Z-2225-2008: GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-2225-2008 |
|---|---|
| Recall event | 48689 |
| Product | GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K052293 |
| 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