| | Class 2 Device Recall NvisionVLE |  |
| Date Initiated by Firm | April 11, 2018 |
|---|
| Create Date | May 09, 2018 |
|---|
| Recall Status1 |
Terminated 3 on August 20, 2018 |
| Recall Number | Z-1781-2018 |
|---|
| Recall Event ID |
79884 |
| 510(K)Number | K143678 |
|---|
| Product Classification |
System, imaging, optical coherence tomography (oct) - Product Code NQQ
|
| Product | 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. |
|---|
| Code Information |
Lot Numbers: 005196, 005251, 005275 |
| FEI Number |
3008805841
|
Recalling Firm/
Manufacturer |
Ninepoint Medical Inc.
12 Oak Park Dr
Bedford MA 01730-1443
|
| For Additional Information Contact | Eman Namati
855-900-7135 |
|---|
Manufacturer Reason
for Recall | Distal tips of the probes may detach from the probe shaft during use. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 152 |
|---|
| Distribution | US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = NQQ
|
|---|
|
|
|
