Events

Rappel de Device Recall Fraxel re:store Dual Laser System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Solta Medical, Inc..

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
    57595
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1010-2011
  • Date de mise en oeuvre de l'événement
    2010-12-15
  • Date de publication de l'événement
    2011-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96741
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Powered laser surgical instrument with microbeam\fractional output - Product Code ONG
  • Cause
    The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
  • Action
    The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.

Device

Device Recall Fraxel re:store Dual Laser System
  • Modèle / numéro de série
    Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
  • Description du dispositif
    Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. || 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; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA || The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
  • Manufacturer
    Solta Medical, Inc.

Manufacturer

Solta Medical, Inc.
  • Adresse du fabricant
    Solta Medical, Inc., 25881 Industrial Blvd, Hayward CA 94545-2991
  • Société-mère du fabricant (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA