FDA Enforcement
Class II
Terminated
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.
Recall: Z-1781-2018
·
Reported May 16, 2018
Enforcement
- Recall Number
- Z-1781-2018
- Event ID
- 79884
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ninepoint Medical Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 16, 2018
- Initiation Date
- April 11, 2018
- Classification Date
- May 9, 2018
- Termination Date
- August 20, 2018
- Address
- 12 Oak Park Dr, N/A, Bedford, MA, 01730-1443, United States
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
Distal tips of the probes may detach from the probe shaft during use.
Code Info
Lot Numbers: 005196, 005251, 005275
Distribution
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
Quantity
152