Device recall
Z-0983-2022: GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0983-2022 |
|---|---|
| Recall event | 89842 |
| Product | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier… |
| Product code | LNH |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211980 |
| 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