# FDA recall Z-2729-2017

> **Natus Neurology Inc** · Class II · device recall initiated 2017-06-09.

## Product

Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500.    Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

## Reason for recall

Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.

## Distribution

Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and, to the countries of Australia, Canada, Chile, Columbia, Germany, India, Japan, Jordan, Kuwait, Netherlands, Papua Guinea, Philippines, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, and United Kingdom.

## Key facts

- **Recall number:** Z-2729-2017
- **Recalling firm:** Natus Neurology Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-09
- **Report date:** 2017-07-19
- **Termination date:** 2020-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middleton, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2729-2017

## Citation

> AI Analytics. FDA recall Z-2729-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2729-2017. Source: US FDA. Licensed CC0.

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