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Recall Observatory FDA recall evidence

Device product

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

Z-1984-2023

April 21, 2023

Class II

Product summary

Firm
Masimo Corporation
Event
Event 92371
Status
Ongoing
Classification
Class II
Quantity
86 units
Official record key
device-enforcement:Z-1984-2023

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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