BEUDAMED
    FDA Enforcement Class II Ongoing

    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

    Recall: Z-1539-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1539-2024
    Event ID
    94170
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Masimo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2024
    Initiation Date
    February 15, 2024
    Classification Date
    April 12, 2024
    Address
    52 Discovery, Irvine, CA, 92618-3105, United States

    Description

    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

    Reason

    Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

    Code Info

    UDI:(01)00843997013789/ Serial Numbers: 6000083849 6000083870 6000083875 6000083898 6000083909 6000083932 6000083941 6000083959 6000083974 6000083978 6000083983 6000083991 6000083997 6000083999 6000084011 6000084018 6000084020 6000084042 6000084055 6000084075 6000084084 6000084090 6000084101 6000084106 6000084112 6000084132 6000084133 6000084157 6000084163 6000084181 6000084205 6000084211 6000084222 6000084236 6000084276 6000084290 6000084364 6000084392 6000084394 6000084429 6000084439 6000084442 6000084454 6000084455 6000084457 6000084513 6000084536 6000084543 6000084567 6000084574 6000084575 6000084607 6000084613 6000084647 6000090319 6000090325 6000090331 6000090333 6000090339 6000084465 6000083931 6000083954 6000083963 6000084250 6000084309

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia, Congo, The Democratic Republic of, Costa Rica, Cyprus, Czech Republic, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Lesotho, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Poland, Puerto Rico, Qatar, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tanzania, United Republic Of, Thailand, Trinidad And Tobago, Uganda, United Kingdom, Uruguay, Yemen, Zimbabwe.

    Quantity

    65