medical Class II Updated 2018-05-16

Ninepoint Medical Inc. recalls NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 9550

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 005196, 005251, 005275
View official government recall

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