Events

Recall of Omron 3Way Instant Thermometer

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

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
    33801
  • Event Risk Class
    Class 2
  • Event Number
    Z-0466-06
  • Event Initiated Date
    2005-10-25
  • Event Date Posted
    2006-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42461
  • 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
    Thermometer, Electronic, Clinical - Product Code FLL
  • Reason
    Omron is recalling the omron 3-way instant thermometers due to possible overheating of the probe tip.
  • Action
    Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert consumers who may have purchased the thermometer at a retail pharmacy, and has posted both the press release and the recall letter on their website at www.omronhealthcare.com.

Device

Omron 3Way Instant Thermometer
  • Model / Serial
    Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Canada, Chile, Venezuela and Singapore
  • Product Description
    Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philippines; UPC 73796-43600
  • Manufacturer
    Omron Healthcare, Inc.

Manufacturer

Omron Healthcare, Inc.
  • Manufacturer Address
    Omron Healthcare, Inc., 1200 Lakeside Dr, Bannockburn IL 60015-1243
  • Source
    USFDA