Events

Alerte De Sécurité sur Avant, Avant LW and Salsa

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

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
    2012-03-08
  • 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_20120309b.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
    Field safety notice: etac avant, avant lw and salsa it comes to our attention that there were 4 registered incidents involving the walker avant and 1 registered incident involving the walker salsa manufactured by etac supply center due to wheels coming off in ten year period. when delivered from etac, the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and then cannot be fastened properly. another error may occur if the lock ring is mounted without ensuring that it fits into the groove all the way around the axle. both of these assembling errors may give the impression that the wheels are properly fastened, but such wheel can come off if it gets struck or hits an obstacle that affects the wheel sideways. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Avant, Avant LW and Salsa
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Etac Avant, Avant LW and Salsa
  • Manufacturer
    Etac Supply Center

Manufacturer

Etac Supply Center