Home / Recalls / Medical Devices
Masimo Corporation recalls Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Recalled June 28, 2023 · FDA recall Z-1984-2023 · Masimo
Hazard
TC-I tip clip sensor may produce readings outside the accuracy specification. · FDA Class II
Units
86 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 LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Manufacturer(s)
Masimo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →