Device recall
Z-2339-2015: GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-2339-2015 |
|---|---|
| Recall event | 71788 |
| Product | GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx… |
| Product code | LNH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 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