Device recall
Z-1100-2013: GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1100-2013 |
|---|---|
| Recall event | 64763 |
| Product | GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of… |
| Product code | LNH |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2014 |
| 510(k) numbers | K103327 |
| 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