Home / Recalls / Natus Neurology Inc / Z-2727-2017

Z-2727-2017 Class II Terminated

Recalled by Natus Neurology Inc — Middleton, WI

FDA device recall Z-2727-2017 was initiated by Natus Neurology Inc on June 9, 2017 and is designated Class II. 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. The recall status is terminated (terminated July 22, 2020). Affected quantity: 2,335 units total.

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
June 9, 2017
Termination Date
July 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,335 units total

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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.

Other recalls by Natus Neurology Inc

  • Z-1305-2024 Class II — TENSIVE Conductive Adhesive Gel, REF 016-401600 (February 7, 2024)
  • Z-1306-2024 Class II — natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX (February 7, 2024)
  • Z-2568-2018 Class II — Nicolet¿ Ambulatory EEG (February 1, 2018)
  • Z-2729-2017 Class II — Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. In (June 9, 2017)
  • Z-2726-2017 Class II — Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code (June 9, 2017)
  • Z-2728-2017 Class II — Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended (June 9, 2017)
  • Z-0117-2016 Class II — NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data (September 11, 2015)

FDA data resources