Events

Rappel de Omron 3Way Instant Thermometer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Omron Healthcare, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    33801
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0466-06
  • Date de mise en oeuvre de l'événement
    2005-10-25
  • Date de publication de l'événement
    2006-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42461
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Thermometer, Electronic, Clinical - Product Code FLL
  • Cause
    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
  • Modèle / numéro de série
    Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Canada, Chile, Venezuela and Singapore
  • Description du dispositif
    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.
  • Adresse du fabricant
    Omron Healthcare, Inc., 1200 Lakeside Dr, Bannockburn IL 60015-1243
  • Source
    USFDA