BEUDAMED
    FDA Recall Terminated

    CARESCAPE Respiratory Module E-sCAiO

    Recall: Z-0756-2020 · Initiated September 27, 2019

    Recall

    Recall Number
    Z-0756-2020
    Event Number
    84034
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 27, 2019
    Posted
    January 10, 2020
    Terminated
    September 26, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    CARESCAPE Respiratory Module E-sCAiO

    Reason

    Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.

    Action

    The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: 1) Connect the module to the host device; 2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes; 3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions; 4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and 5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform. 6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. Contact GE Healthcare Service or your local Service Representative. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom

    Quantity

    161 units