Events

Retiro De Equipo (Recall) de NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sybaritic, Inc.

¿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
    51704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1444-2009
  • Fecha de inicio del evento
    2008-04-12
  • Fecha de publicación del evento
    2009-09-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81043
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Sybaritic inc. had an issue with the 585nm filter used with the nannolight mp50. the filter may cause unwanted burning and should not be used for vascular lesion treatments.
  • Acción
    A "Sybaritic" notification letter dated April 15, 2008 was issued to consignees. The letter described the modifications to the protocols for the NannoLight MP50 and the temporary replacement of 585 Filter for the 560 Filter for Vascular Lesions until further notice. They requested the immediate use of the protocols replacing all other versions. A follow-up letter dated June 3, 2008 was issued to customers. The letter included an attachment " Product Notice Nannolight MP50 585 nm "special" filter from Sybaritic, Inc. The letter described the new 585 nm "bandwidth filter". Also the notification advised consignees to discontinue the use of the old 585 filter and to use 560nm filter until they receive the new 585 nm bandwidth filter. Please direct any questions to your Account Manager or to Sybaritic, Inc. by calling 1-800-445-8418 or 1-952-888-8282.

Device

NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
  • Modelo / Serial
    Serial Numbers:   272102 280103 280104 280105 280901 281004 280810 280506 280509 280609 280808 280809 281304 280801 280206 280301 280306 280207 280402 280702 280703 280403 280405 280701 280701 280706 280210 280303 280805 280802 280108 280208 280302 280508 280604 280906 280908 280909 280910 281001 280804 280905 280209 280803 280409 280510 280610 280401 280709 280806 280708 280307 280807 280904 281005 280902 280304 280503 280507 and 281204.  Serial numbers sumbitted 4/22/09.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (states of WA, CA, MN, FL and AR), POLAND, THAILAND, CHILE, CANADA, KOREA, AZERBAIJAN, INDIA, SPAIN, ARGENTINA, RUSSIA, GREECE, PHILIPPINES, POLAND, INDIA, JORDAN, TURKEY, MEXICO, URUGUAY,BELGIUM, LEBANON, BULGARIA and SINGAPORE.
  • Descripción del producto
    Sybaritic, NannoLight MP50. || Model Numbers and Description: || 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional || laser handpiece when purchased separately), Subassembly || (unit only, no safety glasses, owner's manual, etc. included); || 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; || 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform || configuration; || 4.) 404207-B Completed unit, matte finish, 220 Volt; || 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; || 6.) 404208-B Completed unit, matte finish, 110 Volt; and || 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform || configuration. || The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • Dirección del fabricante
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA