Device recall
Z-1098-2016: Intra operative MRI Systems: Neuro II-SE, Neuro III-SV, iMRI 1.5T A, and iMRI…
FDA device recall · Class II · Deerfield Imaging
Key facts
| Recall number (Z-number) | Z-1098-2016 |
|---|---|
| Recall event | 73421 |
| Product | Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD). |
| Product code | LNH |
| Recalling firm | Deerfield Imaging |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2017 |
| 510(k) numbers | K061916, K071099, K083137, K133692 |
| FEI number | 3010326005 |
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