Device recall
Z-3279-2018: Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-3279-2018 |
|---|---|
| Recall event | 80264 |
| Product | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10… |
| Product code | LNH |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2022 |
| 510(k) numbers | K142085 |
| FEI number | 2183553 |
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