Events

Recall of rainbow Reusable Sensors

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
    72626
  • Event Risk Class
    Class 2
  • Event Number
    Z-0338-2016
  • Event Initiated Date
    2015-10-28
  • Event Date Posted
    2015-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141684
  • 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
    These sensors were manufactured with incompatible configurations. this could result in sensors that will provide either no readings or inaccurate readings for the spco and spmet parameters.
  • Action
    Masimo sent an Urgent Product Recall letter on October 28, 2015, to all affected customers to inform them that Masimo has identified specific lots of sensors that were manufactured with incompatiable configurations. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete the tracking/verification form and email to Masimo. Customers with questions were instructed to contact Masimo Technical Services at http://Service.Masimo.com. For questions regarding this recall call 949-297-7000.

Device

rainbow Reusable Sensors
  • Model / Serial
    2201 2407 2696 2697
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
  • Product Description
    rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
  • Manufacturer
    Masimo Corporation

Manufacturer

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