FDA Medical Device Recalls (openFDA)
Natus Neurology Inc: 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.
- Recall number
- Z-2727-2017
- Recalling firm
- Natus Neurology 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.
- Status
- Terminated
- Initiated
- 2017-06-09
- Posted
- not on file
- Terminated
- 2020-07-22
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K982635"]
- PMA numbers
- not on file
- Product code
- JAF
- Firm FEI
- 3010611950
- Firm city
- Middleton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28