Recall Z-1781-2018 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Ninepoint Medical Inc.
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 p
| Date | Apr 11, 2018 |
| Status | Terminated |
| Reason | Distal tips of the probes may detach from the probe shaft during use. |
| Root cause | Process control |
| Action | 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 customerservice@ninepointmedical.com, in order to initiate the product return process. Customers with questions may contact the NinePoint Medical Recall Coordinator at (855)900-7195 or customerservice@ninepointmedical.com. |
| Quantity | 152 |
| Distribution | US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory Ninepoint Medical, Inc., Feb 6, 2015 |