Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Reported: June 28, 2023 Initiated: April 21, 2023 #Z-1983-2023
Product Description
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Reason for Recall
TC-I tip clip sensor may produce readings outside the accuracy specification.
Details
- Recalling Firm
- Masimo Corporation
- Units Affected
- 138,926 units
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053. Recalled by Masimo Corporation. Units affected: 138,926 units.
Why was this product recalled? ▼
TC-I tip clip sensor may produce readings outside the accuracy specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2023. Severity: Moderate. Recall number: Z-1983-2023.
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