Natus Neurology Inc recalls Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early dete…

Recall date

June 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2728-2017

FDA classification

Class II

Brand / firm

Natus Neurology Inc

Sold / distributed

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, Ger…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.