Events

Rappel de Device Recall RevLite SI Laser

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 ConBio, a CynoSure Company.

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
    65407
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1599-2013
  • Date de mise en oeuvre de l'événement
    2013-05-09
  • Date de publication de l'événement
    2013-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118789
  • 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 - Product Code GEX
  • Cause
    An inconsistency was identified related to electronic display identification of the optional multilite dye handpieces of the revlite si laser system that may confuse user.
  • Action
    The firm, Cynosure Inc., sent a "MEDICAL DEVICE FIELD ACTIONS NOTIFICATION" letter dated May 9, 2013 to its customers via UPS next day. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the Revlite SI Multilite Dye Handpieces upon receipt of this letter and complete and return the enclosed Field Corrective Action Acknowledgement Form via e-mail to: mflynn@cynosure.com or FAX to: 978-256-6556. A Cynosure representative will be contacting customers to schedule and arrange an exchange of the affected handpieces. If additional information is required please contact VP of Regulatory Affairs and Quality Systems at 978-367-2350 or via email at ikulinets@cynosure.com.

Device

Device Recall RevLite SI Laser
  • Modèle / numéro de série
    659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
  • Description du dispositif
    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. || The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. || Manufactured by: || ConBio, A Cynosure Company || 47733 Fremont blvd || Fremont, CA 94538
  • Manufacturer
    ConBio, a CynoSure Company

Manufacturer

ConBio, a CynoSure Company
  • Adresse du fabricant
    ConBio, a CynoSure Company, 47733 Fremont Blvd, Fremont CA 94538-6512
  • Source
    USFDA