Events

Recall of Radical Handheld 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
    32384
  • Event Risk Class
    Class 2
  • Event Number
    Z-0933-05
  • Event Initiated Date
    2005-06-10
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39936
  • 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
    Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
  • Action
    Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.

Device

Radical Handheld Pulse Oximeter
  • Model / Serial
    Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela, Lithuania, Czech Republic, Belgium, Neterlands, Austria, Switzerland, Egypt, Greece, France Taiwan.
  • Product Description
    Radical Handheld Pulse Oximeter
  • Manufacturer
    Masimo Corporation

Manufacturer

Masimo Corporation
  • Manufacturer Address
    Masimo Corporation, 40 Parker, Irvine CA 92618-1604
  • Source
    USFDA