Events

Recall of Device Recall Elite 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Neurology Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77569
  • Event Risk Class
    Class 2
  • Event Number
    Z-2727-2017
  • Event Initiated Date
    2017-06-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156548
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, ultrasonic, nonfetal - Product Code JAF
  • 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.
  • 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.

Device

Device Recall Elite 2
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Natus Neurology Inc

Manufacturer

Natus Neurology Inc
  • Manufacturer Address
    Natus Neurology Inc, 3150 Pleasant View Rd, Middleton WI 53562-4800
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA