BEUDAMED
    FDA Enforcement Class I Terminated

    CARESCAPE Respiratory Module E-sCOVX

    Recall: Z-0755-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0755-2020
    Event ID
    84034
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    September 27, 2019
    Classification Date
    January 10, 2020
    Termination Date
    September 26, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    CARESCAPE Respiratory Module E-sCOVX

    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.

    Code Info

    Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV19266019HA11190626 SGV14404046HA Not Applicable

    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

    3 units