Ninepoint Medical Inc. recalls NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(1

Recalled May 16, 2018 · FDA recall Z-1781-2018 · Ninepoint Medical

Hazard

Distal tips of the probes may detach from the probe shaft during use. · FDA Class II

Units

152

Sold at

US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX

Description

Distal tips of the probes may detach from the probe shaft during use.

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.

Manufacturer(s)

Ninepoint Medical Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →