Events

Alerte De Sécurité sur STAR Excimer Laser 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 Abbott Medical Optics.

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
    2013-09-25
  • Date de publication de l'événement
    2013-09-25
  • 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_20130925.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: abbott medical optics star excimer laser system medical device manufacturer, abbott medical optics (amo) ltd, has issued a field safety notice concerning amo star excimer laser system. the affected models are s2, s3, s4 and s4 ir. amo is providing an advisory notice to all customers who use the affected products to make aware of an issue that has the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to a specific component found in a limited amount of star systems. if the system is found to have the component, amo will replace a printed circuit board in the laser at the next service visit. in the unlikely event that the star system loses both oblique and ring illumination, users are advised to contact the manufacturer for assistance. in addition, amo recommends users to use the lowest level of illumination required during the patient treatment in order to reduce high use conditions caused by the oblique and ring illumination lamps being on simultaneously. it is recommended that only two oblique lamps be used (not activating the optional third oblique lamp) in order to further reduce the remote possibility of complete illumination loss. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 september 2013.

Device

STAR Excimer Laser System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Medical Optics STAR Excimer Laser System
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics