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Terminated

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.

FDA Recall Z-1781-2018 · Posted None

Recalling FirmNinepoint Medical Inc.
Recall StatusTerminated
Product CodeNQQ
Date Initiated2018-04-11
Date Terminated2018-08-20
Product Quantity152

Reason for Recall

Distal tips of the probes may detach from the probe shaft during use.

Firm 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 [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].

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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