CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report
Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe recalled by Natus Neurology
Natus Neurology is recalling Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, distributed in 44 states. The recall was initiated on 9 Jun 2017 and the FDA has classified it as Class II.
Check your package
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-2727-2017
- 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 Water Proof Probe, Model #: X1L008, Catalog Code: NW20. 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.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
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: CHR0140 CHR0141 CHR0142 CHR0143 CHR0144 CHR0145 CHR0146 CHR0147 CHR0148 CHR0149 CHR0150 CHR0151 CHR0152 CHR0153 CHR0154 CHR0155 CHR0156 CHR0157 CHR0158 CHR0159 CHR0160, and CHR0161.
Where was it sold?
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.
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 77569This 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 |
|---|---|---|---|---|---|
| CLASS II | Nicolet¿ Elite¿ 3 MHz OB Probe recalled by Natus Neurology | Natus Neurology | Other | 44 states | |
| CLASS II | Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor recalled | Natus Neurology | Other | 44 states | |
| CLASS II | Nicolet¿ Elite¿ 5 MHz Vascular Probe recalled by Natus Neurology | Natus Neurology | Other | 44 states |
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|---|---|---|---|---|---|
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