Device recall
Z-1035-2015: This correction applies to all GE Healthcare MRI systems with superconducting…
FDA device recall · Class I · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1035-2015 |
|---|---|
| Recall event | 70209 |
| Product | This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 10, 2015 |
| 510(k) numbers | K012200, K013636, K030874, K040444, K041476 |
| 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