BEUDAMED
    FDA Recall Open, Classified

    GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

    Recall: Z-0312-2021 · Initiated September 17, 2020

    Recall

    Recall Number
    Z-0312-2021
    Event Number
    86531
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 17, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

    Reason

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

    Action

    GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.

    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

    88 devices