Events

Alerte De Sécurité sur Puma, Beatle, Alex and Ibis XP power wheelchairs

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

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
    2011-11-15
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115c.html
  • 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
    Medical Device Safety Alert
  • Cause
    Mhra field safety notice: handicare puma, beatle, alex and ibis xp power wheelchairs the medicines and healthcare products regulatory agency (mhra) has issued a safety notice concerning the compact lights on puma, beatle, alex and ibis xp power wheelchairs manufactured by handicare ltd. handicare explained that the lights might cause overheating and, as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare is now replacing the lights in the compact lights unit by new led lights. this precautionary action will affect puma, beatle, alex and ibis xp power wheelchairs equipped with compact light units sold from november 2003 up to and including september 2011. according to the manufacturer, the majority of the affected products were distributed to the netherlands and also to canada and some european countries. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Puma, Beatle, Alex and Ibis XP power wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs
  • Manufacturer
    Handicare Ltd

Manufacturer

Handicare Ltd
  • Source
    DH