# FDA recall Z-1781-2018

> **Ninepoint Medical Inc.** · Class II · device recall initiated 2018-04-11.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1781-2018
- **Recalling firm:** Ninepoint Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-11
- **Report date:** 2018-05-16
- **Termination date:** 2018-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2018

## Citation

> AI Analytics. FDA recall Z-1781-2018. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1781-2018. Source: US FDA. Licensed CC0.

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