Recall Z-1781-2018— Ninepoint Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Ninepoint Medical Inc., initiated 2018-04-11, terminated 2018-08-20. It names one FDA 510(k) clearance: K143678. 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.. Reason: Distal tips of the probes may detach from the probe shaft during use..
- Recalling firm
- Ninepoint Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-11
- Terminated
- 2018-08-20
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.