Device recall
Z-1492-2012: GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1.5T…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1492-2012 |
|---|---|
| Recall event | 61413 |
| Product | GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus… |
| Product code | MOS |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2012 |
| 510(k) numbers | K103335 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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