Device recall
Z-1890-2008: GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1890-2008 |
|---|---|
| Recall event | 48073 |
| Product | GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body. |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2012 |
| 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