Events

Rappel de Fraxel Dual 1550/1927 Laser Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Solta Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00402-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00402-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Solta medical australia has determined that some customers may have obsolete versions of fraxel dual laser labelling (user manual and treatment settings card).The two obsolete documents incorrectly provided parameter settings for the treatment of melasma using the 1927 nm wavelength laser. only the 1550 nm wavelength has approved indications for use for the treatment of melasma.While both issues were corrected prior to 27 october, 2010, customers may not have received a corrected version of the labelling.-revision a of the 10-05170 re: store dual user manual, released on 27 august,2009 incorrectly stated the 1927 nm laser was indicated for melasma.This was corrected on revision b of 10-05170. -mk 3100 revisions a and b, fraxel re: store dual laser treatment settings card, effective from 2nd december 2009 - 27th october 2010 incorrectly stated the 1927 nm laser was indicated for melasma.This error was corrected on revision c of mk 3100.
  • Action
    Solta Medical Australia is requesting their customers to return affected versions of the User Manual or Treatment Settings Card. Replacement information will be provided to customers.

Device

Fraxel Dual 1550/1927 Laser Systems
  • Modèle / numéro de série
    Fraxel Dual 1550/1927 Laser SystemsModel Number: MC-SYS-SR1500-DMultiple serial numbers affectedARTG Number: 141041
  • Manufacturer
    Solta Medical Australia Pty Ltd

Manufacturer

Solta Medical Australia Pty Ltd
  • Source
    DHTGA