Device recall
Z-0597-2022: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0597-2022 |
|---|---|
| Recall event | 89376 |
| Product | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system. |
| Product code | LNH |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143251 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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