Device recall
Z-1781-2018: NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5…
FDA device recall · Class II · Ninepoint Medical Inc.
Key facts
| Recall number (Z-number) | Z-1781-2018 |
|---|---|
| Recall event | 79884 |
| Product | NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used… |
| Product code | NQQ |
| Recalling firm | Ninepoint Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2018 |
| 510(k) numbers | K143678 |
| FEI number | 3008805841 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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