Z-2727-2017Class II

Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive...

Name: Z-2727-2017 Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive...
Creator: Natus Neurology Inc
Published: 2017-06-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-06-09 / Terminated

FDA source

Natus Neurology Inc began a recall of 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... on 2017-06-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2727-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-09
Posted: 2017-07-13
Terminated: 2020-07-22
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: JAF Monitor, Ultrasonic, Nonfetal
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: Customer notification via an Urgent Recall Notification/Field Notice began 06/09/2017. The letter identified the affected product and the reason for the recall. Customers were asked to complete and return the attached verification form. The firm will replace functioning probes that returned free of charge. Customers are to follow the instructions provided for returning any affected devices.
Quantity in commerce: 2,335 units total
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2727-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2726-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13
Z-2727-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13
Z-2728-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13
Z-2729-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13

Product code JAF

K982635Class IICaredop IINicolet Biomedical / cleared 1998-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)