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
- Recall Number
- Z-1781-2018
- Event Number
- 79884
- Firm
- Ninepoint Medical Inc.
- FEI Number
- 3008805841
- Product Code
- NQQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 11, 2018
- Terminated
- August 20, 2018
- Address
- 12 Oak Park Dr, Bedford, MA, 01730-1443
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.
Distal tips of the probes may detach from the probe shaft during use.
On April 11, 2018 Ninepoint Medical Inc. mailed Urgent Medical Device Recall letters to affected customers. Customers were instructed to examine inventory for the affected product, discontinue use of affected product, complete a recall response form or send the information via email to [email protected], in order to initiate the product return process. Customers with questions may contact the NinePoint Medical Recall Coordinator at (855)900-7195 or [email protected].
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
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