Events

Alerte De Sécurité sur Fraxel re:store Dual 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 Solta Medical Inc..

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
    2011-02-11
  • 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/press_20110211.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
    Press release
  • Cause
    Safety concern on fraxel re:store dual laser systemthe department of health (dh) today (february 11) warned healthcare professionals and beauty industry operators that the fraxel re:store dual laser system runs the risk of causing inadvertent laser firing which may lead to patient/operator injury. dh, through its routine surveillance on medical devices, noticed that the us food and drug administration (fda) has announced that the product’s manufacturer, solta medical inc., is recalling all the affected devices for corrective actions. fraxel re:store dual laser system is a laser surgical instrument for use in general and plastic surgery and in dermatology. a dh spokesman said: "there is a risk of causing skin burn under high energy setting and small spot size." the model numbers and serial numbers of the devices involved are - model numbers: mc-sys-sr1500-d-us; mc-sys-sr1500-d-us-loaner; mc-sys-sr1500-d-upg-us; mc-sys-sr 1500-0-1 ntl; mc-sys-sr1500-d-i-loaner; mc-sys-sr1500-d-upg-intl serial numbers: f1196j, j0007, j0010-j0058, j0060-j0203, j0205, j0207-j0209, j0211-j0337, j0339-j0359, j0361-j0414, j0417-j0419, j0426 according to the information from local supplier, solta medical inc., at least three machines were imported to hong kong. two were sold to local healthcare professionals and one was used as a demonstration machine. the supplier has contacted the local users for immediate corrective actions. so far, the dh has not received any report of adverse events arising from use of the affected products. dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant. while dh will continue to monitor the development, the spokesman urged healthcare professionals and operators of beauty parlours who are using the affected device to stop using it, and contact the local supplier for immediate corrective actions. ends/friday, february 11, 2011.

Device

Fraxel re:store Dual Laser System
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety concern on Fraxel re
  • Manufacturer
    Solta Medical Inc.

Manufacturer

Solta Medical Inc.