Device recall
Z-0194-2018: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
FDA device recall · Class I · Monteris Medical Corp
Key facts
| Recall number (Z-number) | Z-0194-2018 |
|---|---|
| Recall event | 78315 |
| Product | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. |
| Product code | GEX |
| Recalling firm | Monteris Medical Corp |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 21, 2021 |
| 510(k) numbers | K171255 |
| 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