BEUDAMED
    FDA Enforcement Class II Ongoing

    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

    Recall: Z-1984-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1984-2023
    Event ID
    92371
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Masimo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 28, 2023
    Initiation Date
    April 21, 2023
    Classification Date
    June 21, 2023
    Address
    52 Discovery, Irvine, CA, 92618-3105, United States

    Description

    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

    Reason

    TC-I tip clip sensor may produce readings outside the accuracy specification.

    Code Info

    UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ

    Distribution

    US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    86 units