Events

Recall of Device Recall Pulse Oximeter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Masimo Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57700
  • Event Risk Class
    Class 2
  • Event Number
    Z-1387-2011
  • Event Initiated Date
    2010-12-23
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97029
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Oximeter - Product Code DQA
  • 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.
  • 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.

Device

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

Manufacturer

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