BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1984-2023 · Initiated April 21, 2023

    Recall

    Recall Number
    Z-1984-2023
    Event Number
    92371
    Firm
    Masimo Corporation
    FEI Number
    3011353843
    Product Code
    DQA
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 21, 2023
    Posted
    June 21, 2023
    Address
    52 Discovery, Irvine, CA, 92618-3105

    Description

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

    Reason

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

    Action

    On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. 3. Complete Attachment 1, then email it to [email protected], or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

    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