Alerte De Sécurité sur Omron 3-Way Instant Thermometers

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Omron Healthcare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2005-11-03
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Voluntary recall of two models of omron® 3-way instant thermometers by omron healthcare, inc. 3 november 2005 the department of health (dh) noted a voluntary recall of two models of battery-operated digital thermometers produced by omron healthcare, inc. today (3 november). dh advised the public to stop using the models concerned. no complaint or report of serious injury has been received by dh or the company so far. the recall was initiated by the company following reports of the potential problem of overheating of the tip of the device, resulting in users' discomfort and possibly redness or blister. very young children using these products are at a higher risk because of their inability to express themselves clearly and the difficulty in pulling away the device held by an adult. the affected products are omronr 3-way instant thermometers, with model numbers mc-600 and mc-600can and lot numbers beginning with 01-32, 01-36, 01-37 and 01-38. the lot numbers can be found inside the battery compartments of the thermometers. members of the public can call the telephone hotline of the company at 2796 2907 during office hours (monday to friday 9 am - 5:30pm and saturday 9 am - 1 pm) for enquiries.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Press release: Voluntary Recall of Two Models of Omron® 3-Way Instant Thermometers by Omron Healthcare, Inc.
  • Manufacturer

Manufacturer