FDA Medical Device Recalls (openFDA)
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 provides two-dimensional, cross-sectional, real-time depth visualization.
- Recall number
- Z-1781-2018
- Recalling firm
- Ninepoint Medical Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-04-11
- Posted
- not on file
- Terminated
- 2018-08-20
- 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
- Lot, serial or model codes
- Lot Numbers: 005196, 005251, 005275
- 510(k) numbers
- ["K143678"]
- PMA numbers
- not on file
- Product code
- NQQ
- Firm FEI
- 3008805841
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28