BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

    Recall: Z-1427-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1427-2022
    Event ID
    90422
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    May 27, 2022
    Classification Date
    July 20, 2022
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

    Reason

    The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

    Code Info

    Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.

    Distribution

    Distribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, and WV. There was also military distribution but no government distribution. Foreign distribution was made to Australia, Canada, China, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Malaysia, New Zealand, Philippines, Romania, Russia, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    667 devices