Events

Retiro De Equipo (Recall) de Fraxel Dual 1550/1927 Laser Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Solta Medical Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00402-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00402-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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