BEUDAMED
    FDA Recall Terminated

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    Recall: Z-2728-2017 · Initiated June 9, 2017

    Recall

    Recall Number
    Z-2728-2017
    Event Number
    77569
    Firm
    Natus Neurology Inc
    FEI Number
    3010611950
    Product Code
    JAF
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 9, 2017
    Terminated
    July 22, 2020
    Address
    3150 Pleasant View Rd, Middleton, WI, 53562-4800

    Description

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    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.

    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.

    Quantity

    2,335 units total