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Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Recalled June 28, 2023 · FDA recall Z-1985-2023 · Masimo
Hazard
TC-I tip clip sensor may produce readings outside the accuracy specification. · FDA Class II
Units
443,799 units
Sold at
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.
Description
TC-I tip clip sensor may produce readings outside the accuracy specification.
Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Manufacturer(s)
Masimo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →