Events

Alerte De Sécurité sur Endeavor Light System

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

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
    2013-12-30
  • Date de publication de l'événement
    2013-12-30
  • 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_20131230.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
    Medical device safety alert: orascoptic endeavor light system medical device manufacturer, orascoptic, has issued a medical device safety alert concerning its endeavour light system [part no.: 910114-x; serial no.: 78100100 to 78113815]. the manufacturer is informing end users of a possible light output issue with the endeavour light system, which was shipped to place of distribution from november 2011 through august 2013. the manufacturer discovered that intermittent to no light output may occur without proper placement of the spiral temple clip that was provided with the initial purchase. this clip is a critical component of the endeavour light system that should be used to secure the cable to the temple arm of the frame. as a preventive measure, a complimentary spiral temple clip is offered to end users along with instructions on how to place the clip as a means to secure the cable to the temple arm of his/her loupes and prevent strain on the cable that allows power to reach the headlight led. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 december 2013.

Device

Endeavor Light System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Orascoptic Endeavor Light System
  • Manufacturer
    Orascoptic

Manufacturer

Orascoptic