FDA Device recall Z-1781-2018
NvisionVLE¿ Low-Profile Optical Probe
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of NvisionVLE¿ Low-Profile Optical Probe by Ninepoint Medical, citing distal tips of the probes may detach from the probe shaft during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1781-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ninepoint Medical |
| Distribution | US |
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 for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.
Reason
Distal tips of the probes may detach from the probe shaft during use.
Identifiers
| code_info | Lot Numbers: 005196, 005251, 005275 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1781-2018%22
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