Masimo Corporation: 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.

Recall number

Z-1387-2011

Recalling firm

Masimo Corporation

Product

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.

Status

Terminated

Initiated

2010-12-23

Posted

2011-02-22

Terminated

2013-03-26

Reason

Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement.

Root cause

Process design

Action

Masimo sent an Urgent Voluntary Medical Device Recall letter dated December 21, 2010, to all affected customers via FexEx on December 23, 2010. The Urgent Voluntary Recall Notice provides instructions on the actions that the customers and field personnel must take to correct the issue. Customers were instructed to choose any of the three options below. Option 1 would ensure accurate results are achieved when using the Pronto-7 rainbow 4D Reusable Sensor with the Pronto-7 Spot Check Pulse CO-Oximeter. (1) Option 1: Prior to performing an SpHb measurement, wait at least seven (7) minutes with the patient's finger inserted inside the Pronto-7 rainbow 4D Reusable Sensor. The seven minute wait will help ensure that the actual finger temperature and the sensor temperature are close to equalized. Masimo is working to quickly develop a revision to the Pronto-7 rainbow 4D Reusable Sensor that will address this issue and plan to have it available in early 2011. We will contact you when the new revision of the sensor becomes available to replace the current sensor; (2) Option 2: Return only the Pronto-7 rainbow 4D Reusable Sensor and request a loaner Pronto device with rainbow DCI sensor (part numbers 9167 and 2646) to be utilized until the new version of the sensor is available for use with the Pronto-7. Please let us know if you wish to try the Pronto or see the product brochure for Pronto. We will contact you when the new revision of the sensor becomes available; (3) Option 3: In addition, the Pronto-7 rainbow 4D Reusable Sensor and the Pronto-7 Spot Check Pulse CO-Oximeter may be returned for a refund. Customers were also instructed to complete the Tracking/Verification Form provided with the recall notice and fax it to Masimo at: 1-949-297-7499.

Quantity

497

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

Lot, serial or model codes

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

510(k) numbers

["K100403"]

PMA numbers

not on file

Product code

DQA

Firm FEI

3001452206

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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