Device recall
Z-0255-2016: GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0255-2016 |
|---|---|
| Recall event | 72301 |
| Product | GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2018 |
| 510(k) numbers | K013636 |
| 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