Device recall
Z-0259-2016: GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0259-2016 |
|---|---|
| Recall event | 72301 |
| Product | GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device. |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2018 |
| 510(k) numbers | K052293, K132376 |
| 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