Device 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.
Z-1781-2018
Product summary
- Event
- Event 79884
- Status
- Terminated
- Classification
- Class II
- Quantity
- 152
- Official record key
device-enforcement:Z-1781-2018
Official wording
Reason: Distal tips of the probes may detach from the probe shaft during use.
Code information: Lot Numbers: 005196, 005251, 005275
Distribution pattern: US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
Derived failure modes
-
Unknown
Distal tips of the probes may detach from the probe shaft during use.