BEUDAMED
    FDA Enforcement Class II Ongoing

    Flow Sensor Service Part, Catalog 2089610-001-S

    Recall: Z-0315-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0315-2021
    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

    Flow Sensor Service Part, Catalog 2089610-001-S

    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). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

    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

    4794 units