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U.S. Department of Health and Human Services

Class 2 Device Recall Pulse Oximeter

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 Class 2 Recall
Pulse Oximeter
see related information
Date Posted February 22, 2011
Recall Status1 Terminated on March 26, 2013
Recall Number Z-1387-2011
Recall Event ID 57700
Premarket Notification
510(K) Number
K100403 
Product Classification Oximeter - Product Code DQA
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.
Code Information 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
Recalling Firm/
Manufacturer
Masimo Corporation
40 and 50 Parker
Irvine, California 92618
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = MASIMO CORPORATION
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