Devices

Device Recall Pulse Oximeter

Model / Serial
Device Listing Numbers: D111075, E448552, E448553, D111073, E653295 Catalog Numbers and Description: 2468-Rainbow 4D DC Sensor, 10 Spot Checks, US, 1/Box, Masimo, 2468-OU-Rainbow 4D DC Sensor, 10 Spot Checks, International, 1/Box, Masimo, 2482-4D DC Sensor, 500 Spot Checks, US, Refurbished, 1/Box, Masimo, 2920-4D DC Sensor, US, 1/Box, Masimo, 2920-OU-4D DC Sensor, International, 1/Box, Masimo, 2952-4D DC Sensor, 360 Spot Checks, US, 1/Box, Masimo, 2952-OU-4D DC Sensor, 360 Spot Checks, International, 1/Box, Masimo, 2953-4D DC Sensor, 500 Spot Checks, US, 1/Box, Masimo, 2953-OU-4D DC Sensor, 500 Spot Checks, International, 1/Box, Masimo, 2954-4D DC Sensor, 1000 Spot Checks, US, 1/Box, Masimo, 2954-OU-4D DC Sensor, 1000 Spot Checks, International, 1/Box, Masimo, 9147-4D DC Sensor, 1-10,000 Spot Checks, US, 1/Box, Masimo, 9147-OU-4D DC Sensor, 1-10,000 Spot Checks, International, 1/Box, Masimo
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - Nationwide in the US and worldwide to Argentina, Austria, Bahrain, Belgium, Benin, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebaron, Libyan Arab, Jamahiriya, Malaysia, Malta, Mauritius, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United kingdom
Product Description
Masimo Hemoglobin || Pronto-7 with Rainbow 40 Technology for || easy-to-use spot-check testing of hemoglobin (SpHb), || SpO2, pulse rate, and perfusion index || Pronto-7 rainbow 4D Reusable Sensors are an accessory to the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter. The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument) with Masimo Rainbow SET Technology is developed to simultaneously and non-invasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The instrument has a single on/off button and an interactive touchscreen for administering tests along with user selectable options.
Manufacturer
Masimo Corporation
1 Event
- Recall of Device Recall Pulse Oximeter

Manufacturer

Masimo Corporation

Manufacturer Address
Masimo Corporation, 40 and 50 Parker, Irvine CA 92618
Manufacturer Parent Company (2017)
Masimo Corporation
Source
USFDA

One device with a similar name

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Device Recall Pulse Oximeter

Model / Serial
Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Product Description
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).
Manufacturer
Masimo Corporation

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