FDA-Device2013-05-08Class II
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Masimo Corporation
Hazard
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Sold states
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Affected count
42,908 units
Manufactured in
Forty Parker, Irvine, CA, United States
Products
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2013Don't want to check this manually?
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