BEUDAMED
    FDA Enforcement Class II Ongoing

    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

    Recall: Z-0314-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0314-2021
    Event ID
    86531
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2020
    Initiation Date
    September 17, 2020
    Classification Date
    October 30, 2020
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

    Reason

    Flow sensors could have damaged tubes in the form of small punctures or cuts.

    Code Info

    Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

    Distribution

    U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom

    Quantity

    37 devices