BEUDAMED
    FDA Recall Open, Classified

    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

    Recall: Z-0579-2018 · Initiated October 11, 2017

    Recall

    Recall Number
    Z-0579-2018
    Event Number
    78469
    Firm
    GE Medical Systems China Co., Ltd. National Hi-Tech Dev. Zone NO.
    FEI Number
    3003513129
    Product Code
    BSZ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    October 11, 2017
    Address
    19 Changjiang Road, Wuxi China

    Description

    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

    Reason

    Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

    Action

    On approximately 10/11/2017 customers were notified of the recall via letter. Instructions include that if elevated FiCO2 is observed, to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathed. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anesthesia delivery device. GE Healthcare is planning to release revised parts that minimize the likelihood of incomplete gas flow through the CO2 absorbent canister. GE Healthcare will correct all affected devices by installing updated parts at no cost to the customer. The updated parts will be included in the 12-month preventative maintenance schedule for the Carestation 600 Series System.

    Distribution

    Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di'Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.

    Quantity

    5,148 devices