Home / Recalls / Ninepoint Medical Inc. / Z-1781-2018

Z-1781-2018 Class II Terminated

Recalled by Ninepoint Medical Inc. — Bedford, MA

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
April 11, 2018
Termination Date
August 20, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
152

Product Description

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 for Recall

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

Distribution Pattern

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

Code Information

Lot Numbers: 005196, 005251, 005275