Events

Alerte De Sécurité sur Stellaris PC Vision Enhancement System with Integrated Laser

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

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
    2014-11-13
  • Date de publication de l'événement
    2014-11-13
  • 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_20141113.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: bausch & lomb stellaris pc vision enhancement system with integrated laser medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning the stellaris pc vision enhancement system with integrated laser. the affected products are as follows: stellaris pc w/ laser: part number bl14304. stellaris pc w/ laser upgrade: part numbers bl1433 (stellaris pc w v3 software) with bl2272 (laser upgrade kit) and bl14334 (stellaris pc w v4 software) with bl2272 (laser upgrade kit). the manufacturer has identified a software anomaly where it can occur that when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo mode to endo continuous mode) and the system is in “standby”, the system will automatically transition to “ready” to fire state. this defeats one of the several safety mechanisms in the device to prevent inadvertent firing of the laser. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 november 2014.

Device

Stellaris PC Vision Enhancement System with Integrated Laser
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bausch & Lomb Stellaris PC Vision Enhancement System with Integrated Laser
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb