Z-1781-2018 Class II Terminated
FDA device recall Z-1781-2018 was initiated by Ninepoint Medical Inc. on April 11, 2018 and is designated Class II. Reason for recall: Distal tips of the probes may detach from the probe shaft during use. The recall status is terminated (terminated August 20, 2018). Affected quantity: 152.
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