Device recall
Z-0257-2016: GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0257-2016 |
|---|---|
| Recall event | 72301 |
| Product | GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2018 |
| 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