CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor recalled

Natus Neurology is recalling Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, distributed in 44 states. The recall was initiated on 9 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321.

Quantity recalled2,335 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2726-2017
FDA event ID: 77569
Recalling firm: Natus Neurology, Middleton, WI
Classification: Class II
Status: Terminated
Recall initiated: 9 Jun 2017
FDA classified: 13 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

9 Jun 2017	Recall initiated by company
13 Jul 2017	Classified by FDA	+34 days
19 Jul 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

Where it was 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, Germany, India, Japan, Jordan, Kuwait, Netherlands, Papua Guinea, Philippines, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, and United Kingdom.

Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it 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.

Which lots are affected?

Serial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 77569

This product is part of a recall event; the main page for the event is Nicolet¿ Elite¿ 3 MHz OB Probe recalled by Natus Neurology.

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017	CLASS II	Nicolet¿ Elite¿ 3 MHz OB Probe recalled by Natus Neurology	Natus Neurology	Other	44 states
19 Jul 2017	CLASS II	Nicolet¿ Elite¿ 5 MHz Vascular Probe recalled by Natus Neurology	Natus Neurology	Other	44 states
19 Jul 2017	CLASS II	Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe recalled by Natus Neurology	Natus Neurology	Other	44 states

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