Device recall
Z-0227-2015: SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01…
FDA device recall · Class II · Monteris Medical Corp
Key facts
| Recall number (Z-number) | Z-0227-2015 |
|---|---|
| Recall event | 69514 |
| Product | SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The… |
| Product code | GEX |
| Recalling firm | Monteris Medical Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2014 |
| 510(k) numbers | K120561, K131955, K141983 |
| FEI number | 3009970070 |
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