Events

Retiro De Equipo (Recall) de Device Recall Light Sheer Desire Diode Laser System with XC Handpiece Accessory options

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 Lumenis Limited.

¿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
    70863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1519-2015
  • Fecha de inicio del evento
    2015-03-25
  • Fecha de publicación del evento
    2015-04-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135279
  • 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
    Device software treatment preset parameters for the xc treatment handpiece do not match the operator manual, and exceed recommended settings. operator manual parameters are lower than indicated for specific hair color and fitzpatrick skin type resulting in insufficient treatment effect. may result in patient burns and hypopigmentation.
  • Acción
    Lumenis Limited sent an Urgent Safety Advisory Notice dated March 25, 2015, to all affected customers. Customers were instructed that Lumenis is eliminating the potential risk of patient harm through a software upgrade and Operator Manual replacement. The software upgrade must be completed by a Lumenis-certified engineer as soon as possible. In the Interim, customers can continue to use their LightSheer DESIRE system by following the recommendations in the operator manual to always perform a test patch prior to a full treatment. Customers with questions were instructed to contact the Aesthetic Business Unit Product Manager. For questions regarding this recall call 801-656-2690.

Device

Device Recall Light Sheer Desire Diode Laser System with XC Handpiece Accessory options
  • Modelo / Serial
    Lot numbers: XI0017, XI0018, XI0023, XIP0043, 182, 184, 185, XIP0049, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254, 256, 257, XIP0038, XIP0131, XIP0125, 3048, 3052, 3065, 3074, XI0012, XIP0143, XIP0144, XI0001, XIP0072, XI0028, XIP0061, XI0028, XI0036, XIP0074, XIP0077, XIP0082, XIP0087, XIP0132, XIP0127, XIP0124, XIP0129, XI0008, XI0029, XI0037, XI0046, XIP0123, XIP0059, XIP0107, XIP0089, XIP0096, XIP0156, XI0005, XIP0114, XI0014, XI0022, XI0015, XI0021, XI0031, XI0034, XI0024, XI0026, XIP0047, XI0042, XI0039, XIP0044, XIP0025, XIP0035, XIP0041, XIP0030, XIP0051, XIP0057, XIP0113, XIP0067, XIP0053, XIP0083, XIP0058, XIP0055, XIP0060, XIP0066, XIP0163, XIP0071, XIP0063, XIP0120, XIP0088, XIP0081, XIP0064, XIP0050, XIP0101, XIP0062, XIP0095, XIP0121, XIP0094, XIP0108, XIP0105, XIP0122, XIP0119, XIP0104, XIP0097, 104, XIP0065, XIP0164, XIP0159, XIP0152, XIP0166, XI0016, XIP0045, XIP0052, XIP0158, XIP0092, XIP0111, XIP0086, XIP0086, XIP0086, XIP0112, XIP0130, XIP0157, XIP0093, XIP0151, XIP0149, XIP0167, XIP0168, XIP0162, XIP0171, XIP0138, XIP0118
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.
  • Descripción del producto
    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
  • Manufacturer
    Lumenis Limited

Manufacturer

Lumenis Limited
  • Dirección del fabricante
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Empresa matriz del fabricante (2017)
    Laguna Holdco Ltd
  • Source
    USFDA